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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Candidiasis, Vulvovaginal, Mycoses, Yeast Infection, Moniliasis, Vulvovaginal, Vaginitis, Monilial

Intervention / Treatment
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* Drug: CD101 Vaginal Gel (3%)
* Drug: CD101 External gel (1%)
* Drug: CD101 Vaginal Ointment (6%)
* Drug: CD101 External ointment (1%)
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours. | Drug: CD101 Vaginal Gel (3%)<br>* CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2<br>Drug: CD101 External gel (1%)<br>* CD101 external gel (1%) applied topically twice daily over 72 hours as needed<br>|
| Experimental: Cohort 2<br>CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours. | Drug: CD101 Vaginal Ointment (6%)<br>* CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1<br>Drug: CD101 External ointment (1%)<br>* CD101 external ointment (1%) applied topically twice daily over 72 hours as needed<br>|
| Active Comparator: Cohort 3<br>Oral fluconazole (150mg) administered on day 1. | Drug: Fluconazole<br>* oral fluconazole (150mg) on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | adverse events, clinical chemistry and hematology, pelvic exams | Day 28 - 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vulvovaginal Scoring System | Change in clinical signs and subject symptoms of VVC | Day 7 (+/- 2days) | 
| Change in Vulvovaginal Scoring System | Change in clinical signs and subject symptoms of VVC | Day 14 (+/- 2days) | 
| Change in Vulvovaginal Scoring System | Change in clinical signs and subject symptoms of VVC | Day 28 - 35 | 
| Mycological Culture | Culture negative for Candida | Day 7 (+/- 2days) | 
| Mycological Culture | Culture negative Candida | Day 14 (+/- 2days) | 
| Mycological Culture | Culture negative Candida | Day 28 -35 |