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BF-200 ALA Dose-Response in Actinic Keratosis
NCT02799030Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2006
- Primary completion
- Mar 2007
- Sponsor
- Biofrontera
- Modality
- Small Molecules
- Conditions
- actinic keratosis (AK)
01
Overview
Phase 2, randomised, double-blind trial of aminolevulinic acid 10% gel in actinic keratosis (AK) (4 arms), sponsored by Biofrontera. Primary endpoint: Total clearance rate of AK lesions at 12 weeks. Started Oct 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo
BF-200 ALA 0% (Placebo gel)
1% ALA
BF-200 ALA 1%
3% ALA
BF-200 ALA 3%
10% ALA
BF-200 ALA 10% (Ameluz)
03
Who it enrols
Adult patients with 3 to 10 mild to moderate actinic keratosis lesions on the face or bald scalp.
04
Endpoints
Primary
Total clearance rate of AK lesions
Secondary
Percentage of subjects totally cleared
Reduction of Total Lesion Area
Reduction of Lesion Size
Overall Cosmetic Outcome
Local Skin Reactions
Local discomfort
related Adverse Events (AEs)
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