U Reinhold1, T Dirschka2,3, R Ostendorf4, R Aschoff5, C Berking6, W G Philipp-Dormston7, S Hahn8, K Lau8, A Jäger9, B Schmitz10, H Lübbert10, R-M Szeimies11. 1. Dermatological Center Bonn Friedensplatz, Bonn, Germany. 2. Private Practice, Wuppertal-Barmen, Germany. 3. Faculty of Health, University Witten/Herdecke, Witten, Germany. 4. Private Practice, Mönchengladbach, Germany. 5. Department of Dermatology, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany. 6. Department of Dermatology and Allergology, University Hospital, Munich, Germany. 7. Medical Centre Cologne, Cologne, Germany. 8. Accovion GmbH, Eschborn, Germany. 9. Biofrontera Bioscience GmbH, Leverkusen, Germany. a.jaeger@biofrontera.com. 10. Biofrontera Bioscience GmbH, Leverkusen, Germany. 11. Department of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany.
Abstract
BACKGROUND:Multiple actinic keratosis (AK) lesions may arise from the cancerization of large, sun-damaged skin areas. Although photodynamic therapy (PDT) is considered the most effective therapeutic option, the efficacy and safety of field treatment of multiple AK lesions with PDT has never before been tested in a pivotal trial. OBJECTIVES: To evaluate the efficacy, safety and cosmetic outcome of BF-200 ALA (a nanoemulsion formulation containing 10% aminolaevulinic acid hydrochloride) combined with the BF-RhodoLED(®) lamp for the field-directed treatment of mild-to-moderate AK with PDT. METHODS: The study was performed as a randomized, multicentre, double-blind, placebo-controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were enrolled in this study; 87 were randomized (55 patients receivedBF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED (635 nm ± 9 nm) until a total light dose of 37 J cm(-2) was achieved. RESULTS:BF-200 ALA was superior to placebo with respect to patient complete clearance rate (91% vs. 22%, P < 0·0001) and lesion complete clearance rate (94·3% vs. 32·9%, P < 0·0001) after a maximum of two PDTs. The confirmatory analysis of all key secondary variables supported this superiority" should not be skipped since this is an important result. Treatment-emergent adverse events (TEAEs) were experienced by 100% of the BF-200 ALA group and 69% of the placebo group. The most commonly reported TEAEs were TEAEs of the application site. The cosmetic outcome was improved in the BF-200 ALA group compared with placebo. CONCLUSIONS: Field-directed therapy with BF-200 ALA and BF-RhodoLED lamp is highly effective and well tolerated for multiple mild-to-moderate AK lesions, providing greatly improved skin quality.
RCT Entities:
BACKGROUND:Multiple actinic keratosis (AK) lesions may arise from the cancerization of large, sun-damaged skin areas. Although photodynamic therapy (PDT) is considered the most effective therapeutic option, the efficacy and safety of field treatment of multiple AK lesions with PDT has never before been tested in a pivotal trial. OBJECTIVES: To evaluate the efficacy, safety and cosmetic outcome of BF-200 ALA (a nanoemulsion formulation containing 10% aminolaevulinic acid hydrochloride) combined with the BF-RhodoLED(®) lamp for the field-directed treatment of mild-to-moderate AK with PDT. METHODS: The study was performed as a randomized, multicentre, double-blind, placebo-controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were enrolled in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED (635 nm ± 9 nm) until a total light dose of 37 J cm(-2) was achieved. RESULTS:BF-200 ALA was superior to placebo with respect to patient complete clearance rate (91% vs. 22%, P < 0·0001) and lesion complete clearance rate (94·3% vs. 32·9%, P < 0·0001) after a maximum of two PDTs. The confirmatory analysis of all key secondary variables supported this superiority" should not be skipped since this is an important result. Treatment-emergent adverse events (TEAEs) were experienced by 100% of the BF-200 ALA group and 69% of the placebo group. The most commonly reported TEAEs were TEAEs of the application site. The cosmetic outcome was improved in the BF-200 ALA group compared with placebo. CONCLUSIONS: Field-directed therapy with BF-200 ALA and BF-RhodoLED lamp is highly effective and well tolerated for multiple mild-to-moderate AK lesions, providing greatly improved skin quality.
Authors: Nathalie C Zeitouni; Neal Bhatia; Roger I Ceilley; Joel L Cohen; James Q Del Rosso; Angela Y Moore; Gilly Munavalli; David M Pariser; Todd Schlesinger; Daniel M Siegel; Andrea Willey; Mitchel P Goldman Journal: J Clin Aesthet Dermatol Date: 2021-10
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