Acne Vulgaris Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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