A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women With Acute Vulvovaginal Candidiasis
Sano Chemicals Inc
Summary
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of OCF001 Intravaginal Gel in Women with Acute Vulvovaginal Candidiasis
Eligibility
- Age range
- 18–65 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Participants will be selected for study participation, if they meet the following criteria: 1. Female participants, 18-65 years of age, inclusive. 2. Clinical diagnosis of symptomatic VVC or RVVC confirmed at baseline by positive KOH wet mount (i.e., when examined microscopically, vaginal secretions obtained by swab of the vaginal mucosa, placed on a slide and diluted with 10% room temperature potassium hydroxide (KOH) reveal filamentous hyphae/pseudohyphae and/or budding yeast cells). * VSS ≥ 5 * KOH or wet prep positive for budding yeast or pseudohyphae * Vagi…
Interventions
- DrugOCF001 Intravaginal Gel
OCF001 is an antifungal antibiotic that is formulated in a water-miscible viscous gel at concentrations of 0.150 mg / g of gel.
- DrugPlacebo Gel
Placebo (Gel formulation without OCF)
Location
- UAB Sexual Health Research ClinicBirmingham, Alabama