Acne VulgarisPhase 1i-PDTNCT01689935
Reduced Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne (i-PDT)
A Phase 1 study testing 20 % Aminolevulinic Acid, Red light only and Blue light only in people with Acne Vulgaris, run by Massachusetts General Hospital.
Trial summary
This research study aims to compare different methods for helping difficult to treat or scarring (cystic) acne, ALA-PDT and i-PDT. There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been reported to be very efficient for acne treatment since 2000. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- 20 % Aminolevulinic Acid, Red light only and Blue light only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2009to 1 Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 14 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects with ages between 14 and 50 years, male or female.
- Subjects with severe acne lesions (one or more nodules or cysts present) on their backs or face
- Presence of moderate acne on the back and/or face that has been recalcitrant to previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3 months) improvement after using:
- Accutane® for at least one completed treatment cycle, and/or
- Oral antibiotic for ≥ 3 months; and/or
- Topical prescription retinoids (tretinoin - retinoic acid, adapalene, tazarotene or other derivatives) for ≥ 3 months, and/or
Show all 13Show fewer
- Topical benzoyl peroxide 2.5% or higher concentrations for ≥ 3 months
- Hormonal treatments** for ≥ 3 months.
- Willingness to participate in the study
- Willingness to receive ALA-PDT treatment
- Informed consent agreement signed by the subject
- Willingness to follow the treatment schedule and post treatment care requirements
- Willingness to not use topical or systemic (oral) anti-acne medications including medicated shampoo or soap during the study period.
Who cannot join
- Subjects receiving concurrent oral retinoids or antibiotics
- Subjects with chronic use of antibiotics may be included if proven that its use has not changed the severity of their acne. AND
- Chronic use of antibiotic is considered ≥ 2 years of continuous use.
- Scarring or infection of the area to be treated
- Known photosensitivity
- Presence of suntan in the area to be treated
Show all 19Show fewer
- Subjects who have taken medication known to induce photosensitivity in the previous 3 months
- Subjects who have had prior oral retinoid (Accutane®) use within 6 months of entering the study
- Prior oral antibiotic use within 1 month of entering the study (see exclusion #1)
- Topical antibiotic or other topical anti-acne treatments use within 2 weeks of entering the study
- Known anticoagulation or thromboembolic condition
- Subjects who are immunosuppressed
- Subject is unable to comply with treatment, home care or follow-up visits
- Subject is pregnant or breast feeding
- Subject has a history of being on photosensitive medications (thiazides [used to treat high blood pressure], tetracyclines, fluoroquinolones griseofulvin or sulfonamides [used to treat infections], sulfonylureas [used to treat diabetes], calcium channel blockers [used to treat hypertension]. phenothiazines [used to treat serious emotional problems]).
- Known skin sensitivity to blue light
- Porphyria (a disorder of the metabolism that can lead to sensitivity to light)
- Allergies to chemicals called porphyrins
- Subjects who started hormonal treatment (for medical conditions or birth control) within less than 3 months.
About this study
Official title: A Pilot Clinical Trial to Reduce Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne
This research study aims to compare different methods for helping difficult to treat or scarring (cystic) acne, ALA-PDT and i-PDT.
There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.
Read more
Levulan® is applied directly to facial/back acne. This is the way that it is usually applied. Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where the Levulan® was applied is exposed to a red light for activation.
The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin through the skin pores to where the glands are. PDT destroys the glands reducing the acne lesion.
Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure also has some side effects. Some of the side effects include pain, burning sensation during the procedure, and redness, tenderness, and swelling after the procedure.
At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT is aimed at reducing the side-effects of ALA- PDT.
The difference between these two procedures is that i-PDT uses a light source that will prevent Levulan® accumulation in the normal skin surface. The investigators would like to find out if Levulan® will be placed only inside the sebaceous glands.
Read the detailed description
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the right and left. One half of the face or back will receive ALA-PDT and the other half will receive i-PDT. For subjects with back acne, red light and blue light alone will be applied for comparison.
Healthy subjects with difficult to treat moderate or severe acne on the face or back are eligible to enroll.
The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with follow-ups 1, 3 and 6 months after treatment.
- Conditions
- Acne Vulgaris
- Being tested
- 20 % Aminolevulinic Acid, Red light only, Blue light only
- Keywords
- Acne vulgaris, Photodynamic Therapy, Side-effects, Pain
- Medical subject headings
- Acne Vulgaris, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 % Aminolevulinic AcidDrug
Also called 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)
topical medication for ALA-PDT and i-PDT
Red light onlyDevice
Also called Omnilux Revive, 635 nm - LED (Phototherapeutics, Cheshire, UK)
Red Light therapy
Blue light onlyDevice
Also called Omnilux Blue, 415 nm LED (Phototherapeutics, Cheshire, UK)
Blue light only
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No drug, no treatment |
| ALA-PDT | Active comparator | Drug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT Receives: Drug: 20 % Aminolevulinic Acid |
| i-PDT | Experimental | Drug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy Receives: Drug: 20 % Aminolevulinic Acid; Device: Blue light only |
| Red Light only | Active comparator | Red light only - no drug Receives: Device: Red light only |
| Blue light only | Active comparator | Blue light only - no drug Receives: Device: Blue light only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
- Clear: No lesions but erythema and residual hyperpigmentation may be present
- Almost Clear: few scattered comedones and a few (< five) small papules
- Mild:< 50% face involved, many comedones/papules and pustules
- Moderate:> 50% of face involved. Numerous comedones, papules and pustules
- Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts.
- Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.
Measured: 0, 4, 8, 12, 16, 24 and 36 weeks
Secondary outcomes (1)
Pain reduction
Visual Pain Scale - 0 (no pain) -10 (severe pain)
Measured: During, immediately after and 24 h after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study start1 Nov 2009
- Primary completion1 Sep 2013
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689935
- Sponsor's protocol ID
- 2009-P-002352
- Acronym
- i-PDT
- Status last verified
- Sep 2019
- First submitted
- 5 Oct 2011
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial to Reduce Side-Effects of Photodynamic Therapy for the Treatment of Moderate to Severe Acne
- ClinicalTrials.gov ID
- NCT01689935
- Acronym / sponsor ID
- i-PDT / 2009-P-002352
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Photodynamic Therapy, Side-effects, Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2009 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to compare different methods for helping difficult to treat or scarring (cystic) acne, ALA-PDT and i-PDT.
There is an investigational procedure called photodynamic therapy (ALA-PDT) that has been reported to be very efficient for acne treatment since 2000. Photodynamic therapy (PDT) uses a drug called ALA (aminolevulinic acid), which is marketed as Levulan®.
Levulan® is applied directly to facial/back acne. This is the way that it is usually applied. Levulan® is left on the skin for three hours so the skin can absorb it. Next, the skin where the Levulan® was applied is exposed to a red light for activation.
The sebaceous glands get obstructed and inflamed causing acne. ALA gets down under your skin through the skin pores to where the glands are. PDT destroys the glands reducing the acne lesion.
Levulan® is absorbed by normal skin surrounding the oil glands. Therefore, this procedure also has some side effects. Some of the side effects include pain, burning sensation during the procedure, and redness, tenderness, and swelling after the procedure.
At Massachusetts General Hospital's Wellman Center for Photomedicine, the investigators developed another procedure called inhibitory-PDT (i-PDT) that is similar to ALA-PDT. i-PDT is aimed at reducing the side-effects of ALA- PDT.
The difference between these two procedures is that i-PDT uses a light source that will prevent Levulan® accumulation in the normal skin surface. The investigators would like to find out if Levulan® will be placed only inside the sebaceous glands.
Detailed description
This is a pilot study to compare efficacy and side effects i-PDT and ALA-PDT. All subjects will receive ALA-PDT and i-PDT. Face or back regions will be divided into two sides, the right and left. One half of the face or back will receive ALA-PDT and the other half will receive i-PDT. For subjects with back acne, red light and blue light alone will be applied for comparison.
Healthy subjects with difficult to treat moderate or severe acne on the face or back are eligible to enroll.
The investigators will enroll about 35 patients at Massachusetts General Hospital (MGH) with follow-ups 1, 3 and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No drug, no treatment |
| ALA-PDT | Active comparator | Drug: 20 % Aminolevulinic AcidDrug- topical 20% Aminolevulinic acid - ALA followed by red light irradiation - conventional photodynamic therapy -PDT |
| i-PDT | Experimental | Drug: 20 % Aminolevulinic Acid, Device: Blue light onlyDrug - topical 20% Aminolevulinic acid - followed by inhibitory light during incubation time, then red light for photodynamic therapy |
| Red Light only | Active comparator | Device: Red light onlyRed light only - no drug |
| Blue light only | Active comparator | Device: Blue light onlyBlue light only - no drug |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Subjects with ages between 14 and 50 years, male or female.
- Subjects with severe acne lesions (one or more nodules or cysts present) on their backs or face
- Presence of moderate acne on the back and/or face that has been recalcitrant to previous treatments. Recalcitrant acne is acne with no or mild/temporary (less than 3 months) improvement after using:
- Willingness to participate in the study
- Willingness to receive ALA-PDT treatment
Key exclusion criteria (19 listed)
- Subjects receiving concurrent oral retinoids or antibiotics
- Subjects with chronic use of antibiotics may be included if proven that its use has not changed the severity of their acne. AND
- Chronic use of antibiotic is considered ≥ 2 years of continuous use.
- Scarring or infection of the area to be treated
- Known photosensitivity
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 |
|---|---|---|
| 20 % Aminolevulinic AcidAlso: 5-Aminulevulinic acid HCl (ALA): Levulan® Kerastic® (Dusa Pharmaceuticals, Inc, Wilmington, MA, USA) (Dusa Pharmaceuticals)topical medication for ALA-PDT and i-PDT | Drug | ALA-PDT, i-PDT |
| Red light onlyAlso: Omnilux Revive, 635 nm - LED (Phototherapeutics, Cheshire, UK)Red Light therapy | Device | Red Light only |
| Blue light onlyAlso: Omnilux Blue, 415 nm LED (Phototherapeutics, Cheshire, UK)Blue light only | Device | Blue light only, i-PDT |
Primary outcome
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris
Time frame: 0, 4, 8, 12, 16, 24 and 36 weeks
0. Clear: No lesions but erythema and residual hyperpigmentation may be present 1. Almost Clear: few scattered comedones and a few (< five) small papules 2. Mild:< 50% face involved, many comedones/papules and pustules 3. Moderate:> 50% of face involved. Numerous comedones, papules and pustules 4. Severe: Entire face is covered with comedones, numerous papules and pustules and a few nodules and cysts. 1) Clear or almost clear (Grades 0 or 1) as success at 12 weeks. 2) Two grade improvement as success at 12 weeks.
1 secondary outcome
Pain reduction
Time frame: During, immediately after and 24 h after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 20 % Aminolevulinic Acid, Red light only and Blue light only in people with Acne Vulgaris, run by Massachusetts General Hospital.
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 13 inclusion and 19 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy: Investigator Global Assessment (IGA) scale for acne vulgaris (time frame: 0, 4, 8, 12, 16, 24 and 36 weeks). 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 20 Feb 2025.