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

ABSTRACT:

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%).

SUBMITTER: Rijsbergen M 

PROVIDER: S-EPMC7576619 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature