3 completed, 1 active not recruiting, 1 unknown. 3 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 2 | Active not recruiting 1, Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis) Aminolevulinic acid hydrochloride 10% topical gel with Red Light - Cutaneous Squamous Cell Carcinoma | Phase 2 | Unknown | The Center for Clinical and Cosmetic Research | 20 | 2024-08-14 | 2024-08-29 |
| Short Contact Protocols to Reduce Pain During 10% ALA Gel Red-light Photodynamic Therapy of Actinic Keratoses Topical aminolevulinate (10% ALA gel), Red light illumination - Actinic Keratosis | Phase 2 | Completed | Case Comprehensive Cancer Center | 30 | 2023-10-02 | 2025-10-23 |
| 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 BF-200 ALA and red light LED lamp, Vehicle and red light LED lamp - Actinic Keratoses | Phase 3 | Completed | Biofrontera Inc. | 172 | 2022-12-12 | 2026-08-21 |
| Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris With Photodynamic Therapy in Adults 1h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), 1h Incubation Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient), 3h Incubation Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) - Acne Vulgaris | Phase 2 | Completed | Biofrontera Inc. | 120 | 2021-12-10 | 2026-10-01 |
| Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) - Superficial Basal Cell Carcinoma | Phase 3 | Active not recruiting | Biofrontera Inc. | 187 | 2018-09-25 | 2026-01-14 |
Keratosis, Actinic (2) · Acne Vulgaris (1) · Carcinoma, Squamous Cell (1) · Skin Neoplasms (1) · Squamous Intraepithelial Lesions (1)
1-phenyl-3,3-dimethyltriazene (2) · Aminolevulinic Acid (2) · BF-200 ALA (1) · Gels (1) · Photochemotherapy (1) · Red Light (1)
United States (5)
David M. Pariser, MD (1) · Edward V Maytin, M.D. Ph.D. (1) · Mark S Nestor, MD, PhD (1) · Mitchel P Goldman, MD (1) · Nathalie Zeitouni, MD (1)