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

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