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Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus‐induced genital lesions
- Source :
- British Journal of Clinical Pharmacology, 86(11), 2133-2143, Br J Clin Pharmacol, British Journal of Clinical Pharmacology, 86(11), 2133-2143. WILEY
- Publication Year :
- 2020
- Publisher :
- Wiley, 2020.
-
Abstract
- AIMS\nMETHODS\nRESULTS\nCONCLUSION\n 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).\nTwo 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.\nTwenty-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.\nTopical 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.
- Subjects :
- medicine.medical_specialty
Alphapapillomavirus
Placebo
030226 pharmacology & pharmacy
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Quality of life
law
Internal medicine
pharmacodynamics
Humans
Medicine
Pharmacology (medical)
Genitalia
030212 general & internal medicine
Adverse effect
Papillomaviridae
Pharmacology
business.industry
Papillomavirus Infections
Original Articles
medication safety
Confidence interval
virology
dermatology
Tolerability
Pharmacodynamics
Quality of Life
business
pharmacokinetics
Viral load
Antimicrobial Cationic Peptides
Subjects
Details
- ISSN :
- 13652125 and 03065251
- Volume :
- 86
- Database :
- OpenAIRE
- Journal :
- British Journal of Clinical Pharmacology
- Accession number :
- edsair.doi.dedup.....104cf9465ea20dda8eefd2f093804662