Acne VulgarisPhase 2NCT00706433
Light Dose Ranging Study of Photodynamic Therapy (PDT) With Levulan + Blue Light Versus Vehicle + Blue Light in Severe Facial Acne
A Phase 2 study testing aminolevulinic acid HCL (ALA) in people with Acne Vulgaris, run by DUSA Pharmaceuticals, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- aminolevulinic acid HCL (ALA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 14 sitesUnited States
- Study dates
- Mar 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is male or non-pregnant female 12 years of age or older.
- Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
- Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
- Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
- Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
- Subject is willing to comply with study instructions and return to the clinic for required visits.
- Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin \& Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin \& Hair Care for the entire study.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
- Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
- Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
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- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
- Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
- Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
- Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
- Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
- Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment.
- Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Derm Research Inc
Austin, Texas, 78759
Downstate Med Ctr
Brooklyn, New York, 11203
Laser and Skin Surger Center of Indiana
Carmel, Indiana, 46032
Baylor Research Institute
Dallas, Texas, 75246
Cherry Creek Research, Inc.
Denver, Colorado, 80209
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Derm Research PLLC
Louisville, Kentucky, 40217
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124
Therapeutics Clinical Research
San Diego, California, 92123
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, 30078
Kenneth R. Beer, M.D. P.A.
West Palm Beach, Florida, 33401
About this study
Official title: A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris
The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
Read the detailed description
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group light dose ranging study of photodynamic therapy in subjects with moderate to severe facial acne vulgaris.
Subjects will be randomized to one of the following four treatment groups (1:1:1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
- Group 2 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
- Group 3 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
- Group 4 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Each subject may receive up to four treatments at three week (± 2 days) intervals. The power density (dose rate) and the total fluence (light dose) used at each treatment is intended to remain constant throughout each subject's participation. If a subject meets or exceeds the criteria restricting retreatment (CRR) prior to retreatment (Section 5.6), he/she will not receive additional PDT treatment at that visit and will be asked to return for the next scheduled PDT visit 3 weeks later, if applicable.
Post-treatment follow-up visits will be scheduled to occur at 3 and 6 weeks after the subject's final PDT.
Grading of the subject's facial acne will be conducted by a blinded evaluator who will remain blinded with respect to the subject's treatment assignment. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.
Safety will be evaluated by adverse events and local skin responses reported during the study.
- Conditions
- Acne Vulgaris
- Being tested
- aminolevulinic acid HCL (ALA), Vehicle (VEH)
- Keywords
- Photodynamic Therapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid HCL (ALA)Drug
Also called Levulan, Levulan Kerastick
Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
Vehicle (VEH)Other
Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.
| Study group | Role | What they receive |
|---|---|---|
| ALA 1000 seconds | Active comparator | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Receives: Drug: aminolevulinic acid HCL (ALA) |
| ALA 500 seconds | Active comparator | Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) Receives: Drug: aminolevulinic acid HCL (ALA) |
| Vehicle 1000 seconds | Placebo comparator | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) Receives: Other: Vehicle (VEH) |
| Vehicle 500 seconds | Placebo comparator | Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) Receives: Other: Vehicle (VEH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Lesion Counts Relative to Baseline
Measured: Baseline and 3 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Measured: Baseline and 3 weeks after final treatment
Secondary outcomes (75)
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Measured: Baseline and 3 weeks after final treatment
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Measured: Baseline and 6 weeks after final treatment
Subject Satisfaction Score
Subject satisfaction score
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = Poor (not satisfied at all)
Measured: 6 weeks after final treatment
Change in Inflammatory Lesion Counts Relative to Baseline
change in lesion counts compared to baseline
Measured: Baseline and 6 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.
0 Clear skin with no inflam or non-inflam lesions
- Almost clear; rare non-inflam lesions with no more than a few small inflam lesions
- Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)
- Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule
- Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
Measured: Baesline and 6 weeks after final treatment
Hyperpigmentation 48 Hours After PDT #1
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: 48 hours after PDT #1
Hyperpigmentation at Visit 3 (Week 3)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Visit 3 (Week 3)
Hyperpigmentation at Visit 5 (Week 6)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Visit 5 (Week 6)
Hyperpigmentation at Visit 7 (Week 9)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Visit 7 (Week 9)
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Visit 9 (3 weeks after final PDT)
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Measured: Visit 10 (6 weeks after final PDT)
Hypopigmentation 48 Hours Post PDT #1
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: 48 hours post PDT #1
Hypopigmentation at Visit 3 (Week 3)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Visit 3 (Week 3)
Hypopigmentation at Visit 5 (Week 6)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Visit 5 (Week 6)
Hypopigmentation at Visit 7 (Week 9)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Visit 7 (Week 9)
Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Visit 9 (3 weeks after final PDT)
Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Measured: Visit 10 (6 weeks after final PDT)
Erythema at Baseline (Pre-light)
After solution application, prior to light treatment
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Baseline (pre-light)
Erythema at Baseline - Post Light Treatment
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Baseline - post light treatment
Erythema 48 Hours After PDT #1
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: 48 hours after PDT #1
Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 3 (Week 3 - pre study drug application)
Erythema at Visit 3 (Week 3 - Pre-light)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 3 (Week 3 - pre-light)
Erythema at Visit 3 (Week 3 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 3 (Week 3 - post light treatment)
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 5 (Week 6 - prior to study drug application)
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 5 (Weeks 6 - pre-light treatment)
Erythema at Visit 5 (Week 6 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 5 (Week 6 - post light treatment)
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 7 (Week 9 - prior to study drug application)
Erythema at Visit 7 (Week 9 - Pre Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 7 (Week 9 - pre light treatment)
Erythema at Visit 7 (Week 9 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: Visit 7 (Week 9 - post light treatment)
Erythema 3 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: 3 Weeks after Final PDT
Erythema 6 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Measured: 6 Weeks after Final PDT
Edema at Baseline - Pre Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Baseline - pre light treatment
Edema at Baseline - Post Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Baseline - Post Light Treatment
Edema 48 Hours After PDT #1
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 48 hours after PDT #1
Edema at Visit 3 (Week 3 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 3 (Week 3 - before study drug application)
Edema at Visit 3 (Week 3 - Before Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 3 (Week 3 - before light treatment)
Edema at Visit 3 (Week 3 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 3 (Week 3 - post light treatment)
Edema at Visit 5 (Week 6 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 5 (Week 6 - before study drug application)
Edema at Visit 5 (Week 6 - Pre Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 5 (Week 6 - pre light treatment)
Edema at Visit 5 (Week 6 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 5 (Week 6 - post light treatment)
Edema at Visit 7 (Week 9 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 7 (Week 9 - before study drug application)
Edema at Visit 7 (Week 9 - Prior to Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 7 (Week 9 - prior to light treatment)
Edema at Visit 7 (Week 9 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: Visit 7 (Week 9 - post light treatment)
Edema 3 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 3 weeks after final PDT
Edema 6 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Measured: 6 weeks after final PDT
Stinging/Burning at Baseline - Before Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Baseline - before light treatment
Stinging/Burning at Baseline - During Light
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Baseline - during light
Stinging/Burning at Baseline - Post Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Baseline - post light treatment
Stinging/Burning 48 Hours Post PDT #1
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: 48 hours post PDT #1
Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 3 (Week 3 - before study drug application)
Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 3 (Week 3 - before light treatment)
Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 3 (Week 3 - during light treatment)
Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 3 (Week 3 - post light treatment)
Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 5 (Week 6 - before study drug application)
Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 5 (Week 6 - prior to light treatment)
Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 5 (Week 6 - during light treatment)
Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 5 (Week 6 - post light treatment)
Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 7 (Week 9 - before study drug application)
Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 7 (Week 9 - prior to light treatment)
Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 7 (Week 9 - during light treatment)
Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 7 (Week 9 - post light treatment)
Stinging/Burning at Visit 9 (3 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 9 (3 Weeks after Final PDT)
Stinging/Burning at Visit 10 (6 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Measured: Visit 10 (6 Weeks after Final PDT)
Scaling and Dryness 48 Hours After PDT #1
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: 48 hours after PDT #1
Scaling and Dryness at Visit 3 (Week 3)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Visit 3 (Week 3)
Scaling and Dryness at Visit 5 (Week 6)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Visit 5 (Week 6)
Scaling and Dryness at Visit 7 (Week 9)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Visit 7 (Week 9)
Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Visit 9 (3 Weeks after Final PDT)
Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Measured: Visit 10 (6 Weeks after Final PDT)
Oozing/Vesiculation/Crusting 48 Hours After PDT #1
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: 48 hours after PDT #1
Oozing/Vesiculation/Crusting at Visit 3 (Week 3)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Visit 3 (Week 3)
Oozing/Vesiculation/Crusting at Visit 5 (Week 6)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Visit 5 (Week 6)
Oozing/Vesiculation/Crusting at Visit 7 (Week 9)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Visit 7 (Week 9)
Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Visit 9 (3 Weeks after Final PDT)
Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Measured: Visit 10 (6 Weeks after Final PDT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startMar 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Marcus, M.D., PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706433
- Sponsor's protocol ID
- DUSA-CP0103
- Status last verified
- Oct 2011
- First submitted
- 24 Jun 2008
- Last updated
- 24 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00706433
- Acronym / sponsor ID
- DUSA-CP0103
- Conditions
- Acne Vulgaris
- Keywords
- Photodynamic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 21 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
Detailed description
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group light dose ranging study of photodynamic therapy in subjects with moderate to severe facial acne vulgaris.
Subjects will be randomized to one of the following four treatment groups (1:1:1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH).
- Group 1 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
- Group 2 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
- Group 3 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds)
- Group 4 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds)
Each subject may receive up to four treatments at three week (± 2 days) intervals. The power density (dose rate) and the total fluence (light dose) used at each treatment is intended to remain constant throughout each subject's participation. If a subject meets or exceeds the criteria restricting retreatment (CRR) prior to retreatment (Section 5.6), he/she will not receive additional PDT treatment at that visit and will be asked to return for the next scheduled PDT visit 3 weeks later, if applicable.
Post-treatment follow-up visits will be scheduled to occur at 3 and 6 weeks after the subject's final PDT.
Grading of the subject's facial acne will be conducted by a blinded evaluator who will remain blinded with respect to the subject's treatment assignment. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.
Safety will be evaluated by adverse events and local skin responses reported during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALA 1000 seconds | Active comparator | Drug: aminolevulinic acid HCL (ALA)Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
| ALA 500 seconds | Active comparator | Drug: aminolevulinic acid HCL (ALA)Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) |
| Vehicle 1000 seconds | Placebo comparator | Other: Vehicle (VEH)Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) |
| Vehicle 500 seconds | Placebo comparator | Other: Vehicle (VEH)Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is male or non-pregnant female 12 years of age or older.
- Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
- Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
- Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
- Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
Key exclusion criteria (17 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
- Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
- Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
- Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aminolevulinic acid HCL (ALA)Also: Levulan, Levulan KerastickLevulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals. | Drug | ALA 1000 seconds, ALA 500 seconds |
| Vehicle (VEH)Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals. | Other | Vehicle 1000 seconds, Vehicle 500 seconds |
Primary outcome
Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Time frame: Baseline and 3 weeks after final treatment
Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
75 secondary outcomes
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 6 weeks after final treatment
Subject Satisfaction Score
Time frame: 6 weeks after final treatment
Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 6 weeks after final treatment
Investigator Global Assessment of Acne Severity Successes
Time frame: Baesline and 6 weeks after final treatment
Hyperpigmentation 48 Hours After PDT #1
Time frame: 48 hours after PDT #1
Hyperpigmentation at Visit 3 (Week 3)
Time frame: Visit 3 (Week 3)
Hyperpigmentation at Visit 5 (Week 6)
Time frame: Visit 5 (Week 6)
Hyperpigmentation at Visit 7 (Week 9)
Time frame: Visit 7 (Week 9)
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
Time frame: Visit 9 (3 weeks after final PDT)
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
Time frame: Visit 10 (6 weeks after final PDT)
Hypopigmentation 48 Hours Post PDT #1
Time frame: 48 hours post PDT #1
Hypopigmentation at Visit 3 (Week 3)
Time frame: Visit 3 (Week 3)
Hypopigmentation at Visit 5 (Week 6)
Time frame: Visit 5 (Week 6)
Hypopigmentation at Visit 7 (Week 9)
Time frame: Visit 7 (Week 9)
Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
Time frame: Visit 9 (3 weeks after final PDT)
Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
Time frame: Visit 10 (6 weeks after final PDT)
Erythema at Baseline (Pre-light)
Time frame: Baseline (pre-light)
Erythema at Baseline - Post Light Treatment
Time frame: Baseline - post light treatment
Erythema 48 Hours After PDT #1
Time frame: 48 hours after PDT #1
Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
Time frame: Visit 3 (Week 3 - pre study drug application)
Erythema at Visit 3 (Week 3 - Pre-light)
Time frame: Visit 3 (Week 3 - pre-light)
Erythema at Visit 3 (Week 3 - Post Light Treatment)
Time frame: Visit 3 (Week 3 - post light treatment)
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
Time frame: Visit 5 (Week 6 - prior to study drug application)
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
Time frame: Visit 5 (Weeks 6 - pre-light treatment)
Erythema at Visit 5 (Week 6 - Post Light Treatment)
Time frame: Visit 5 (Week 6 - post light treatment)
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
Time frame: Visit 7 (Week 9 - prior to study drug application)
Erythema at Visit 7 (Week 9 - Pre Light Treatment)
Time frame: Visit 7 (Week 9 - pre light treatment)
Erythema at Visit 7 (Week 9 - Post Light Treatment)
Time frame: Visit 7 (Week 9 - post light treatment)
Erythema 3 Weeks After Final PDT
Time frame: 3 Weeks after Final PDT
Erythema 6 Weeks After Final PDT
Time frame: 6 Weeks after Final PDT
Edema at Baseline - Pre Light Treatment
Time frame: Baseline - pre light treatment
Edema at Baseline - Post Light Treatment
Time frame: Baseline - Post Light Treatment
Edema 48 Hours After PDT #1
Time frame: 48 hours after PDT #1
Edema at Visit 3 (Week 3 - Before Study Drug Application)
Time frame: Visit 3 (Week 3 - before study drug application)
Edema at Visit 3 (Week 3 - Before Light Treatment)
Time frame: Visit 3 (Week 3 - before light treatment)
Edema at Visit 3 (Week 3 - Post Light Treatment)
Time frame: Visit 3 (Week 3 - post light treatment)
Edema at Visit 5 (Week 6 - Before Study Drug Application)
Time frame: Visit 5 (Week 6 - before study drug application)
Edema at Visit 5 (Week 6 - Pre Light Treatment)
Time frame: Visit 5 (Week 6 - pre light treatment)
Edema at Visit 5 (Week 6 - Post Light Treatment)
Time frame: Visit 5 (Week 6 - post light treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Marcus, M.D., PhD study director
Sponsor GmbH
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aminolevulinic acid HCL (ALA) in people with Acne Vulgaris, run by DUSA Pharmaceuticals, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Lesion Counts Relative to Baseline (time frame: Baseline and 3 weeks after final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2011.