Acne VulgarisPhase 2NCT00673933
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris
A Phase 2 study testing Methyl aminolevulinate (MAL) PDT in people with Acne Vulgaris, run by Photocure at 2 sites in United States.
Trial summary
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Methyl aminolevulinate (MAL) PDT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Dec 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female and male patients, age 15 to 40 years with acne vulgaris.
- Patients with skin type V or VI (Fitzpatrick).
- Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
- Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
- Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
- Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.
- Patients must sign the approved informed consent form prior to any study procedures.
- Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.
Who cannot join
- Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
- Participation in other clinical studies either concurrently or within the last 30 days.
- Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
- Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
- Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.
- Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.
- Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.
- Patients with a washout period for oral isotretinoin of less than 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DuPage Medical Group
Naperville, Illinois, 60563
About this study
Official title: A Blinded, Randomized, Intra-individual, Vehicle-controlled and Multi-centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.
Read the detailed description
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.
Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2
- Conditions
- Acne Vulgaris
- Being tested
- Methyl aminolevulinate (MAL) PDT
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl aminolevulinate (MAL) PDTDrug
Cream application followed by illumination with red light
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PDT using MAL crem Receives: Drug: Methyl aminolevulinate (MAL) PDT |
| 2 | Placebo comparator | PDT using Placebo cream Receives: Drug: Methyl aminolevulinate (MAL) PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Measured: 4 weeks after last treatment, 6 weeks after baseline
Secondary outcomes (5)
Erythema Score (Mild and Moderate)Immediately After First PDT
Patients with mild or moderate erythema after first treatment at baseline.
Measured: Immediately after treatment at baseline
Change in Inflammatory Lesion Counts From Baseline
Measured: 4 weeks after last treatment, 6 weeks after baseline
Change in Noninflammatory Lesion Counts From Baseline
Measured: 4 weeks after last treatment, 6 weeks after baseline
Erythema Score (Mild and Moderate)Immediately After Second Treatment
Patients with mild or moderate erythema after second treatment.
Measured: Immediately after second treatment, 2 weeks after baseline
Erythema Score (Mild and Moderate)1 Day After First Treatment
Patients with mild or moderate erythema 1 day after first treatment.
Measured: 1 day after 1st treatment and baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 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, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photocure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashish C Bhatia, MD, Principal investigator, Dermatology Institute of DuPage Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673933
- Sponsor's protocol ID
- PC TA203/08
- Status last verified
- Jul 2013
- First submitted
- 5 May 2008
- Last updated
- 12 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Randomized, Intra-individual, Vehicle-controlled and Multi-centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris
- ClinicalTrials.gov ID
- NCT00673933
- Acronym / sponsor ID
- PC TA203/08
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PhotocureIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 12 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.
Detailed description
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.
Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methyl aminolevulinate (MAL) PDTPDT using MAL crem |
| 2 | Placebo comparator | Drug: Methyl aminolevulinate (MAL) PDTPDT using Placebo cream |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Female and male patients, age 15 to 40 years with acne vulgaris.
- Patients with skin type V or VI (Fitzpatrick).
- Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.
- Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.
- Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.
Key exclusion criteria (8 listed)
- Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.
- Participation in other clinical studies either concurrently or within the last 30 days.
- Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.
- Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.
- Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.
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 |
|---|---|---|
| Methyl aminolevulinate (MAL) PDTCream application followed by illumination with red light | Drug | 1, 2 |
Primary outcome
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Time frame: 4 weeks after last treatment, 6 weeks after baseline
5 secondary outcomes
Erythema Score (Mild and Moderate)Immediately After First PDT
Time frame: Immediately after treatment at baseline
Change in Inflammatory Lesion Counts From Baseline
Time frame: 4 weeks after last treatment, 6 weeks after baseline
Change in Noninflammatory Lesion Counts From Baseline
Time frame: 4 weeks after last treatment, 6 weeks after baseline
Erythema Score (Mild and Moderate)Immediately After Second Treatment
Time frame: Immediately after second treatment, 2 weeks after baseline
Erythema Score (Mild and Moderate)1 Day After First Treatment
Time frame: 1 day after 1st treatment and baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
- 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.
Ashish C Bhatia, MD principal investigator
Dermatology Institute of DuPage Medical Group
2 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 Methyl aminolevulinate (MAL) PDT in people with Acne Vulgaris, run by Photocure at 2 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 8 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 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 12 Jul 2013). 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?
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment (time frame: 4 weeks after last treatment, 6 weeks after baseline). 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 12 Jul 2013.