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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Cream application followed by illumination with red light
DuPage Medical Group
Naperville, Illinois, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
Time frame: 4 weeks after last treatment, 6 weeks after baseline
Erythema Score (Mild and Moderate)Immediately After First PDT
Patients with mild or moderate erythema after first treatment at baseline.
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
Patients with mild or moderate erythema after second treatment.
Time frame: 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.
Time frame: 1 day after 1st treatment and baseline
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