A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of a Nanoemulsion Gel Formulation BF-200 ALA, in Comparison With Metvix® and Placebo, for the Treatment of Actinic Keratosis With PDT

NCT02799069 Phase 3 COMPLETED Results posted

The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.

Details

Lead sponsor	Biofrontera Bioscience GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	571
Start date	2008-04
Completion	2009-08

Conditions

• Actinic Keratosis

Interventions

• BF-200 ALA
• MAL Cream
• Vehicle

Primary outcomes

• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT — 12 weeks after the last PDT, up to 24 weeks after the first treatment
  An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)
• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP — 12 weeks after the last PDT, up to 24 weeks after the first treatment
  An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)
• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only — 12 weeks after the last PDT, up to 24 weeks after the first treatment
  Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (\~630 nm). An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)