Phase 2a Study of OCF001 Intravaginal Gel for Treating Acute Vulvovaginal Candidiasis in Women Aged 18 to 65

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of OCF001 intravaginal gel in women aged 18 to 65 who have acute vulvovaginal candidiasis, a fungal infection of the vagina. This randomized, double-blind, placebo-controlled Phase 2a study aims to assess how well this new antifungal treatment works and how safely it can be used. Women with moderate to severe symptoms and signs of infection confirmed by specific microscopic tests are eligible to participate. Participants will be randomly assigned to receive either 5 grams of OCF001 vaginal gel or a placebo gel once daily for 7 days. The OCF001 gel contains an antifungal antibiotic formulated in a water-friendly gel. The study compares the effects of the active drug against a placebo to evaluate clinical cure after the treatment period. The main treatment phase lasts 7 days, with safety and tolerability monitored over 4 weeks. During the study, participants will be monitored through clinical assessments including vaginal examinations and laboratory tests to confirm infection and evaluate treatment effects. Researchers will track symptoms, signs of infection, and any side effects. Tests such as potassium hydroxide wet mounts and vaginal pH measurements will be used. Follow-up visits will assess clinical cure and local tolerability. The total participation time includes treatment and a 4-week safety evaluation. Participants must comply with study schedules and contraception requirements during the trial.

Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence