Martina Ulrich1, Uwe Reinhold2, Rolf Dominicus3, Roland Aschoff4, Rolf-Markus Szeimies5, Thomas Dirschka6. 1. CMB Collegium Medicum Berlin GmbH, Berlin, Germany. 2. MVZ Dermatologisches Zentrum Bonn GmbH, Bonn, Germany. 3. PRO DERMA, Hautarztzentrum Dülmen, Dülmen, Germany. 4. Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany. 5. Department of Dermatology and Allergology, Klinikum Vest GmbH, Recklinghausen, Germany. 6. CentroDerm GmbH, Wuppertal, Germany and Faculty of Health, University Witten-Herdecke, Witten, Germany. Electronic address: t.dirschka@centroderm.de.
Abstract
BACKGROUND: Actinic keratoses (AK) may occur in all sun-exposed skin areas. Those occurring outside the head area are generally more resistant to treatment than those on the face. OBJECTIVE: To determine efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk, and neck with red light photodynamic therapy (PDT). METHODS: This phase III study had an intra-individual design with 50 patients in 6 centers in Germany. Each patient received a maximum of 2 field-directed PDTs. Clinical end points and 1-year follow-up results were recorded. RESULTS: BF-200 ALA was superior to the vehicle with respect to total lesion clearance rates (86.0% vs 32.9%; P < .0001) and patient complete clearance per patient's side (67.3% vs 12.2%, P < .0001). One-year overall lesion recurrence rate was 14.1% versus 27.4% (BF-200 ALA vs vehicle; P = .0068). Patients were more satisfied by the cosmetic outcome of BF-200 ALA/PDT than the vehicle/PDT. Adverse events were consistent with the known safety profile of BF-200 ALA/PDT. LIMITATIONS: Small number of severe lesions; limited sample size; unbalanced but representative distribution of AK. CONCLUSION: BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.
BACKGROUND: Actinic keratoses (AK) may occur in all sun-exposed skin areas. Those occurring outside the head area are generally more resistant to treatment than those on the face. OBJECTIVE: To determine efficacy and safety of BF-200 ALA versus vehicle in the treatment of mild-to-severe AK located on extremities, trunk, and neck with red light photodynamic therapy (PDT). METHODS: This phase III study had an intra-individual design with 50 patients in 6 centers in Germany. Each patient received a maximum of 2 field-directed PDTs. Clinical end points and 1-year follow-up results were recorded. RESULTS: BF-200 ALA was superior to the vehicle with respect to total lesion clearance rates (86.0% vs 32.9%; P < .0001) and patient complete clearance per patient's side (67.3% vs 12.2%, P < .0001). One-year overall lesion recurrence rate was 14.1% versus 27.4% (BF-200 ALA vs vehicle; P = .0068). Patients were more satisfied by the cosmetic outcome of BF-200 ALA/PDT than the vehicle/PDT. Adverse events were consistent with the known safety profile of BF-200 ALA/PDT. LIMITATIONS: Small number of severe lesions; limited sample size; unbalanced but representative distribution of AK. CONCLUSION: BF-200 ALA showed significantly higher AK clearance rates on extremities, trunk, and neck than the vehicle and was well tolerated.
Authors: Ben Novak; Janet DuBois; Osama Chahrour; Tamara Papusha; Stefan Hirt; Thomas Philippi; Corinna Zogel; Katharina Osenberg; Beate Schmitz; Hermann Lübbert Journal: Clin Pharmacol Drug Dev Date: 2021-10-11