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A Randomized, Double-Blind, Phase III Multi-Center Study Evaluating the Safety and Efficacy of BF-200 ALA Versus Placebo in the Treatment of Actinic Keratosis (AK) When Using PDT
The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.
Details
| Lead sponsor | Biofrontera Bioscience GmbH |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 122 |
| Start date | 2007-12 |
| Completion | 2008-10 |
Conditions
- Actinic Keratosis
Interventions
- Vehicle
- BF-200 ALA
Primary outcomes
- Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT) — 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). - Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT) — 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). - Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT) — 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only \[n=15 (vehicle), n= 31 (BF-200 ALA)\] - Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT) — 12 weeks after the last PDT, up to 24 weeks
AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only \[n=13 (vehicle), n= 28 (BF-200 ALA)\]