RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), & Day 28 (+/-7 days) to assess therapeutic cure and safety.

Inclusion Criteria:

• moderate to severe acute vulvovaginal candidiasis (severity score >7)
• positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
• vaginal pH <4.5 for subjects with positive potassium hydroxide wet preparation
• able to give written informed consent

Exclusion Criteria:

• receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
• known or suspected infectious causes of vulvovaginitis other than candidiasis
• history of genital herpes
• planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
• need for non-protocol systemic or vaginal antifungal therapy
• history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
• pregnant females
• females who are breast feeding
• women intending to become pregnant during the study period
• recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
• subjects who use or anticipate use of intravaginal products
• have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study