NCT00833183

Safety and Efficacy Study of Topical Methyaminlevulinate (MAL) in Subjects With Facial Acne

A Study of Safety and Efficacy of Topical Methylaminolevulinate 80mg/g With and Without Occlusion Followed by Red Light Exposure in Subjects With Facial Acne

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Photocure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study of safety and efficacy of topical methyaminlevulinate 80mg/g with and without occlusion followed by red light exposure in subjects with facial acne.

Detailed description

Photocure ASA has developed a cream formulation containing methyl aminolevulinate (MAL), an ester of ALA. There is extensive experience with the safety of MAL-PDT in humans. This study will assess safety and efficacy of four treatments with methylaminolevulinate (MAL) at 80 mg/g performed with and without occlusion and followed by red light exposure 90 minutes later in subjects with facial acne vulgaris. Subjects will be randomized to one of two groups of 20 subjects: Group 1 will receive 25 J/cm2 of red light (45 mW/cm2) and group 2 will receive 37 J/cm2 of red light (90 mW/cm2). For each subject one side of the face will be randomized to receive MAL for 90 minutes without occlusion and the other side of the face will receive MAL for 90 minutes with occlusion.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	MAL	80 mg/g cream one administration with incubation for 90 minutes

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2009-01-30
• Last updated: 2009-01-30

Locations

2 sites across 1 country: Canada