8 completed, 1 active not recruiting, 1 unknown. 4 Phase 3, 3 Phase 1, 2 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 4 |
| Phase 1 | 3 | Completed 3 |
| Phase 4 | 2 | Active not recruiting 1, Unknown 1 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| Activation of Ameluz With BBL HEROic for the Treatment of Actinic Keratoses and Photodamage Ameluz, Sciton HEROic - Actinic Keratoses, Photodamage | Phase 1 | Completed | Sherrif Ibrahim | 10 | 2025-06-27 | 2026-01-02 |
| Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face Ameluz 10% Topical Gel, Red Light PDT, Cryotherapy - Actinic Keratoses | Phase 4 | Active not recruiting | Psoriasis Treatment Center of Central New Jersey | 40 | 2023-05-03 | 2026-10-14 |
| Comparison of Two Modes of Photodynamic Therapy for the Treatment of Actinic Keratosis on the Upper Extremities aminolevulinic acid hydrochloride gel, 10%, aminolevulinic acid HCl topical solution, 20% - Skin Neoplasms | Phase 4 | Unknown | Goldman, Butterwick, Fitzpatrick and Groff | 20 | 2022-05-15 | 2022-05-04 |
| Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp BF-200 ALA and red light LED lamp - Actinic Keratosis, Keratosis, Actinic | Phase 1 | Completed | Biofrontera Bioscience GmbH | 112 | 2021-12-01 | 2024-10-17 |
| Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK) BF-200 ALA and red light LED lamp - Actinic Keratoses | Phase 1 | Completed | Biofrontera Bioscience GmbH | 48 | 2020-03-05 | 2021-11-11 |
| Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy BF-200 ALA, methyl-aminolevulinate - Basal Cell Carcinoma (BCC) | Phase 3 | Completed | Biofrontera Bioscience GmbH | 281 | 2014-01-28 | 2022-11-03 |
| Safety and Efficacy Study for the Field-directed Treatment of Actinic Keratosis (AK) With Photodynamic Therapy (PDT) BF-200 ALA gel, Placebo to BF-200 ALA gel, Photodynamic therapy with BF-RhodoLED - Actinic Keratosis | Phase 3 | Completed | Biofrontera Bioscience GmbH | 87 | 2013-10-01 | 2023-07-28 |
| Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy BF-200 ALA, MAL Cream, Vehicle - Actinic Keratosis | Phase 3 | Completed | Biofrontera Bioscience GmbH | 571 | 2008-04-01 | 2017-04-28 |
| Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis. Vehicle, BF-200 ALA - Actinic Keratosis | Phase 3 | Completed | Biofrontera Bioscience GmbH | 122 | 2007-12-01 | 2017-04-06 |
| A Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis BF-200 ALA 1%, BF-200 ALA 3%, BF-200 ALA 10% - Actinic Keratosis | Phase 2 | Completed | Biofrontera Bioscience GmbH | 105 | 2006-10-01 | 2016-07-19 |
Keratosis, Actinic (8) · Carcinoma, Basal Cell (1) · Keratosis (1) · Precancerous Conditions (1) · Skin Diseases (1) · Skin Neoplasms (1)
Aminolevulinic Acid (7) · BF-200 ALA (5) · Photochemotherapy (2) · methyl 5-aminolevulinate (2) · 1-phenyl-3,3-dimethyltriazene (1) · Cryotherapy (1) · Gels (1)
United States (5) · Germany (2)
Rolf-Markus Szeimies, Prof Dr (2) · Colin Morton, Dr. (1) · Rolf M. Szeimies, Prof. Dr. (1) · Thomas Dirschka, Prof. Dr. (1) · Todd Schlesinger, MD (1) · Uwe Reinhold, Prof. Dr. (1)
PMID 20518784, PMID 23252768, PMID 29432644, PMID 34633154, PMID 39666443