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A Randomized Placebo-controlled Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis
This was a placebo controlled, double blind, randomized phase II dose-response study to evaluate the efficacy and safety of BF-200 ALA (containing the active ingredient 5 - aminolevulinic acid- ALA) used with photodynamic therapy (PDT) in patients with actinic keratosis (AK).
Details
| Lead sponsor | Biofrontera Bioscience GmbH |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 105 |
| Start date | 2006-10 |
| Completion | 2007-03 |
Conditions
- Actinic Keratosis
Interventions
- BF-200 ALA 1%
- BF-200 ALA 3%
- BF-200 ALA 10%
Primary outcomes
- Total clearance rate of AK lesions — 12 weeks after photodynamic therapy (PDT)
Total clearance rate of all AK lesions, defined as the percentage of baseline lesions within the target treatment areas showing complete remission at week 12 post treatment.