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