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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Photocure · Industry
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Methyl aminolevulinate (MAL) PDT	Cream application followed by illumination with red light

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-05-07
• Last updated: 2013-07-12
• Results posted: 2013-07-12

Locations

2 sites across 1 country: United States