Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05662202 | Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp | PHASE3 | ACTIVE NOT_RECRUITING | 172 | — | — | Dec 12, 2022 | Jun 1, 2026 | May 22, 2026 | 14 | United States |
| NCT04319159 | Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK) | PHASE1 | COMPLETED | 48 | — | — | Mar 5, 2020 | Oct 7, 2020 | Nov 11, 2021 | 1 | United States |
Percentage of subjects with all AK target lesions clinically cleared after last PDT
Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
Blood samples for PpIX analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of PpIX in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods.
| Arm | Type | Description |
|---|---|---|
| BF-200 ALA | EXPERIMENTAL | Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). Red light photodynamic therapy (PDT) |
| Vehicle | PLACEBO_COMPARATOR | Topical application of vehicle to BF-200 ALA containing no active ingredient. Red light photodynamic therapy (PDT) |
| Name | Type | Description |
|---|---|---|
| BF-200 ALA and red light LED lamp | COMBINATION_PRODUCT | Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT): Topical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit. |
| Vehicle and red light LED lamp | COMBINATION_PRODUCT | Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT): Topical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing. PDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit. |
Inclusion Criteria: 1. Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. 2. 4 - 15 mild t...