Evaluation of therapeutic equivalence of amorolfine hydrochloride-containing drugs: results of an open-label randomized multicenter study
- Authors: Samtsov A.V.1, Araviyskaya E.A.2, Kotrechova L.P.3
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Affiliations:
- Kirov Military Medical Academy
- Pavlov First Saint Petersburg State Medical University
- North-Western State Medical University named after I.I. Mechnikov
- Issue: Vol 101, No 1 (2025)
- Pages: 98-108
- Section: GUIDELINES FOR PRACTITIONERS
- URL: https://journals.rcsi.science/0042-4609/article/view/287235
- DOI: https://doi.org/10.25208/vdv16845
- ID: 287235
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Abstract
Background. Tinea pedis is a common superficial fungal skin infection. Amorolfine is one of the topical agents that have demonstrated efficacy in the treatment of mycoses.
Aims. To assess and compare the efficacy of a new agent amorolfine 0.25% cream (Glenmark Pharmaceuticals Ltd., India), versus amorolfine 0.25% cream (Galderma Laboratory, France), registered in the European Union, in the treatment of tinea pedis.
Methods. This open-label, randomized, multicenter, phase III study was conducted with adult patients with tinea pedis. Patients had once-daily amorolfine 0.25% cream (Glenmark Pharmaceuticals Ltd., India) or amorolfine 0.25% cream (Galderma Laboratory, France) applications to the affected skin areas for 28 days. The primary efficacy analysis was performed on the 42nd (± 4) day from the start of therapy, evaluating mycological (based on the results of a potassium hydroxide examination of skin scraping) and clinical (based on the results of symptoms and signs severity assessment) recovery.
Results. In this clinical study,101 patients were randomized to the group 1 — amorolfine 0.25% cream (Glenmark Pharmaceuticals Ltd., India) and 99 patients to the group 2 — amorolfine 0.25% cream (Galderma Laboratory, France). The therapeutic equivalence of the study drugs was confirmed by the percentage of participants recovering as a result of therapy (mycological and clinical) by day 42, amounted to 95.0% in the group 1 and 97.0% in the group 2. The intergroup difference was –1.97% (90% confidence interval: –6.54; 2.60). The upper and lower limits of 90% confidence interval were within the established equivalence margin of 0.2 (р < 0,0001). Among all registered adverse events, there were only 3 treatment-related associated: reaction at the site of application, erythema, and itching in group 2. There were no statistically significant differences between the groups in the incidence of adverse events.
Conclusions. This study demonstrated the therapeutic equivalence of amorolfine 0.25% cream (Glenmark Pharmaceuticals Ltd., India) and amorolfine 0.25% cream (Galderma Laboratory, France). The safety profiles of the study drugs were acceptable and comparable.
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##article.viewOnOriginalSite##About the authors
Alexey V. Samtsov
Kirov Military Medical Academy
Email: avsamtsov@mail.ru
ORCID iD: 0000-0002-9458-0872
SPIN-code: 2287-5062
MD, Dr. Sci. (Med.), Professor, Chief of the Department of Dermatology and Venerology
Russian Federation, 6G, Akademika Lebedeva street, 194044 Saint-PetersburgElena A. Araviyskaya
Pavlov First Saint Petersburg State Medical University
Email: earelenar@mail.ru
ORCID iD: 0000-0002-6378-8582
SPIN-code: 9094-9688
MD, Dr. Sci. (Med.), Professor
Russian Federation, 6-8 Lev Tolstoy street, 197022 Saint PetersburgLubov P. Kotrechova
North-Western State Medical University named after I.I. Mechnikov
Author for correspondence.
Email: Zurupalubov@inbox.ru
ORCID iD: 0000-0003-2995-4249
SPIN-code: 6628-1260
MD, Cand. Sci. (Med.), Associate Professor
Russian Federation, 6 Academician Lebedev street, 194044 Saint PetersburgReferences
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