Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Methyl aminolevulinate (MAL) PDT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PDT using MAL crem | Drug: Methyl aminolevulinate (MAL) PDT<br>* Cream application followed by illumination with red light<br>|
| Placebo Comparator: 2<br>PDT using Placebo cream | Drug: Methyl aminolevulinate (MAL) PDT<br>* Cream application followed by illumination with red light<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment |  | 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 | Patients with mild or moderate erythema after first treatment at baseline. | Immediately after treatment at baseline | 
| Change in Inflammatory Lesion Counts From Baseline |  | 4 weeks after last treatment, 6 weeks after baseline | 
| Change in Noninflammatory Lesion Counts From Baseline |  | 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. | 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. | 1 day after 1st treatment and baseline |