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Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus‐induced genital lesions
Author(s) -
Rijsbergen Melanie,
Rijneveld Rianne,
Todd Marina,
Feiss Gary L.,
Kouwenhoven Stijn T.P.,
Quint Koen D.,
Alewijk Dirk C.J.G.,
Koning Maurits N.C.,
Klaassen Erica S.,
Burggraaf Jacobus,
Rissmann Robert,
Poelgeest Mariëtte I.E.
Publication year - 2020
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14181
Subject(s) - tolerability , medicine , placebo , adverse effect , pharmacodynamics , clinical trial , viral load , genital warts , randomized controlled trial , pharmacokinetics , immunology , cervical cancer , pathology , virus , alternative medicine , cancer
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.