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OCF001 Gel for Vulvovaginal Candidiasis

This study is testing an investigational gel called OCF001 Intravaginal Gel for treating acute vulvovaginal candidiasis (VVC), also known as a yeast infection. Researchers want to see how well OCF001 works compared to a placebo gel (a gel without the active drug) and if it's safe and well-tolerated. You may be able to join if you are a woman between 18 and 65 years old with a confirmed diagnosis of VVC. The main goals are to see if OCF001 can cure the infection after 7 days of treatment and to check for any side effects over 4 weeks. The study is currently unclear on its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either OCF001 Intravaginal Gel or a placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 36 participants.
What's involved
Participants will receive a 7-day intravaginal dose of either OCF001 Intravaginal Gel or a placebo. You will have your clinical cure evaluated at 7 days and safety and tolerability evaluated at 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability for 4 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07521137

Biweekly Long-term Occidiofungin Study for Suppression of Mycotic Recurrence

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Sano Chemicals Inc
~36 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:OCF001 Intravaginal GelPlacebo Gel

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product
Measured over 7 days
+1 more outcome measured

Conditions

Candidiasis, Vulvovaginal

Explore related trials

Vulvovaginal Candidiasis

NCT07521137

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UAB Sexual Health Research Clinic

    Birmingham, Alabamano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christina Muzny, MD · PRINCIPAL_INVESTIGATOR · UAB Sexual Health Research Clinic

Who to contact

James Smith
[email protected]
662-574-5957
Email the study team

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Eligibility criteria

Inclusion

VSS ≥ 5
KOH or wet prep positive for budding yeast or pseudohyphae
Vaginal pH ≤ 4.5 3. Presence of at least one vulvovaginal sign be of at least moderate severity (vulvovaginal erythema, edema, or excoriation) as assessed by the investigator at baseline. 4. Presence of at least one vulvovaginal symptom be of at least moderate severity (vulvovaginal itching, burning, or irritation) as reported by the subject at baseline. 5. Have a body weight range of ≥45kg/99 lbs to ≤110 kg/242 lbs and a body mass index (BMI) of 18-35 kg/m2. 6. Participant is not menstruating at Screening or Day 1 and, based on her menstrual cycle history, is not expected to menstruate during the 7-day intravaginal dosing period. 7. In good general health with no clinically relevant abnormalities based on the medical history, vital signs, physical examination, clinical laboratory evaluations (hematology and clinical chemistry), and 12-lead electrocardiogram (ECG) that, in the opinion of the investigator and sponsor, would affect participant's safety. 8. Participants who are not surgically sterile must use a medically accepted contraceptive regimen for at least 60 days before the baseline visit and agree to continue such use throughout the duration of the study. Reliable forms of contraception include intrauterine devices in place for at least 3 months, oral hormonal contraceptives, and abstinence. Women of childbearing potential must have a negative urine pregnancy test at screening and Day 1. 9. Participants must be non-lactating. 10. Able to provide written informed consent. 11. Able to comply with all protocol-specified assessments and the study visit schedule.

What this trial measures

  • To evaluate the clinical cure of OCF001 (drug product) to treat acute VVC infection following 7-day intravaginal dose of drug product7 days

    Proportion of subjects achieving clinical cure at the Early Response, Test-of-Cure (TOC), and Sustained Response visits (Days 4, 8, and 25), defined as a VSS composite score, VSS total score = 0, and no requirement for additional systemic or topical antifungal therapy for VVC between baseline and TOC.

  • Evaluate the safety and local tolerability of OCF001 (drug product) intravaginal formulation in women with moderate-to-severe acute VVC.4 weeks

    Incidence, severity, and relationship to study drug of treatment-emergent adverse events (TEAEs) from first dose through the end-of-study visits (including local vulvovaginal AEs).