Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions.

Autor: Rijsbergen M; Centre for Human Drug Research, Leiden, the Netherlands., Rijneveld R; Centre for Human Drug Research, Leiden, the Netherlands., Todd M; Centre for Human Drug Research, Leiden, the Netherlands., Feiss GL; Cutanea Life Sciences, Wayne, Pennsylvania, USA., Kouwenhoven STP; Department of Dermatology, Leiden University Medical Centre, Leiden, the Netherlands., Quint KD; Department of Dermatology, Leiden University Medical Centre, Leiden, the Netherlands., van Alewijk DCJG; DDL Diagnostic Laboratory, Rijswijk, the Netherlands., de Koning MNC; DDL Diagnostic Laboratory, Rijswijk, the Netherlands., Klaassen ES; Centre for Human Drug Research, Leiden, the Netherlands., Burggraaf J; Centre for Human Drug Research, Leiden, the Netherlands.; Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands., Rissmann R; Centre for Human Drug Research, Leiden, the Netherlands.; Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands., van Poelgeest MIE; Centre for Human Drug Research, Leiden, the Netherlands.; Department of Gynecology, Leiden University Medical Centre, Leiden, the Netherlands.
Jazyk: angličtina
Zdroj: British journal of clinical pharmacology [Br J Clin Pharmacol] 2020 Nov; Vol. 86 (11), pp. 2133-2143. Date of Electronic Publication: 2020 Sep 28.
DOI: 10.1111/bcp.14181
Abstrakt: Aims: To assess safety and tolerability and explore pharmacodynamics and efficacy of omiganan in external anogenital warts (AGW) and vulvar high-grade squamous intraepithelial lesions (HSIL).
Methods: Two randomized controlled trials in patients with external AGW and vulvar HSIL were conducted. Patients received topical omiganan 2.5% or placebo gel once daily for 12 weeks with a follow-up of 12 weeks. Safety and tolerability were monitored and pharmacodynamics and clinical efficacy of omiganan were assessed by analysing lesion count, size and viral load. Self-reported pain, itch and quality of life were assessed by an electronic diary and questionnaire.
Results: Twenty-four AGW and 12 vulvar HSIL patients were enrolled. All patients had a high treatment adherence (99%). No serious adverse events occurred and all adverse events (n = 27) were mild, transient and self-limiting. The treatment groups were not different in terms of safety and tolerability, lesion count and size, and patient-reported outcomes pain, itch and quality of life. Human papillomavirus load significantly reduced after 12 weeks of treatment with omiganan compared to placebo (-96.6%; 95% confidence interval -99.9 to -7.4%; P = .045) in AGW patients only.
Conclusion: Topical omiganan appears to be safe in patients with AGW and vulvar HSIL and reduced human papillomavirus load after 12 weeks of treatment in AGW patients.
(© 2019 The British Pharmacological Society.)
Databáze: MEDLINE
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