- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00673933
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Naperville, Illinois, United States, 60563
- DuPage Medical Group
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87106
- Academic Dermatology Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
PDT using MAL crem
|
Cream application followed by illumination with red light
|
PLACEBO_COMPARATOR: 2
PDT using Placebo cream
|
Cream application followed by illumination with red light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Time Frame: 4 weeks after last treatment, 6 weeks after baseline
|
4 weeks after last treatment, 6 weeks after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythema Score (Mild and Moderate)Immediately After First PDT
Time Frame: Immediately after treatment at baseline
|
Patients with mild or moderate erythema after first treatment at baseline.
|
Immediately after treatment at baseline
|
Change in Inflammatory Lesion Counts From Baseline
Time Frame: 4 weeks after last treatment, 6 weeks after baseline
|
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
|
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
|
Patients with mild or moderate erythema after second treatment.
|
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
|
Patients with mild or moderate erythema 1 day after first treatment.
|
1 day after 1st treatment and baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashish C Bhatia, MD, Dermatology Institute of DuPage Medical Group
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PC TA203/08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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