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.
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.
Authors: Andrea Trevisan; Nicolas F Schlecht; Agnihotram V Ramanakumar; Luisa L Villa; Eduardo L Franco Journal: J Gen Virol Date: 2013-05-15 Impact factor: 3.891
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Authors: M Rijsbergen; T Niemeyer-van der Kolk; G Hogendoorn; S Kouwenhoven; C Lemoine; E S Klaassen; M de Koning; S Beck; J N Bouwes Bavinck; G Feiss; J Burggraaf; R Rissmann Journal: Br J Dermatol Date: 2019-03-07 Impact factor: 9.302
Authors: Melanie Rijsbergen; Rianne Rijneveld; Marina Todd; Gary L Feiss; Stijn T P Kouwenhoven; Koen D Quint; Dirk C J G van Alewijk; Maurits N C de Koning; Erica S Klaassen; Jacobus Burggraaf; Robert Rissmann; Mariëtte I E van Poelgeest Journal: Br J Clin Pharmacol Date: 2020-09-28 Impact factor: 4.335