Who is sponsoring NCT01966120?

NCT01966120 is sponsored by Biofrontera Bioscience GmbH.

What condition does NCT01966120 study?

NCT01966120 studies Actinic Keratosis.

What drugs are being tested in NCT01966120?

Interventions: BF-200 ALA gel, Placebo to BF-200 ALA gel, Photodynamic therapy with BF-RhodoLED.

What is the status of NCT01966120?

NCT01966120 is currently COMPLETED.

Last reviewed 2023-07-20 · How we verify

A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) Versus Placebo in the Field-directed Treatment of Mild to Moderate Actinic Keratosis With Photodynamic Therapy (PDT) When Using the BF-RhodoLED® Lamp

NCT01966120 Phase 3 COMPLETED Results posted

The purpose of this study is to evaluate the safety and efficacy of BF-200 ALA (Ameluz) versus placebo in the field-directed treatment of mild to moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED lamp.

Details

Lead sponsor	Biofrontera Bioscience GmbH
Phase	Phase 3
Status	COMPLETED
Enrolment	87
Start date	2013-10
Completion	2015-04

Conditions

Actinic Keratosis

Interventions

BF-200 ALA gel
Placebo to BF-200 ALA gel
Photodynamic therapy with BF-RhodoLED

Primary outcomes

Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) — 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed.
Overall Patient Complete Response 12 Weeks After the Last PDT (PP) — 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT
All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed.

Countries

Germany