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CD101 Topical Compared With Oral Fluconazole for Acute Vulvovaginal Candidiasis

A Randomized Controlled Trial

Nyirjesy, Paul MD1; Alessio, Cynthia DO1; Jandourek, Alena MD2; Lee, Jon D. BS2; Sandison, Taylor MD2; Sobel, Jack D. MD3

Journal of Lower Genital Tract Disease: July 2019 - Volume 23 - Issue 3 - p 226–229
doi: 10.1097/LGT.0000000000000473
Original Research Articles: Vulva and Vagina
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Objectives Vulvovaginal candidiasis (VVC) is an infection of the vagina's mucous membranes, caused by Candida albicans in more than 90% of acute VVC. Several topical and oral azole agents are available in a variety of formulations, and all seem to have similar effectiveness. Azoles are fungistatic, meaning that the fungi are inhibited from growth or replication but are not eradicated. Recurrent infection and developing azole resistance demonstrate a significant need for alternative treatments.

Materials and Methods One hundred twenty-six women were randomized to 1 of the following 3 treatment cohorts: CD101 3% gel (n = 50) applied intravaginally on days 1 and 2, CD101 6% ointment (n = 50) applied intravaginally on day 1, or oral fluconazole 150 mg (n = 26) on day 1. Primary outcomes of clinical and mycological cure, as demonstrated by changes in the vaginal scores and mycological culture, were assessed on day 7 (±2 days), day 14 (±2 days), and day 28 (±7 days). Safety assessments included treatment-emergent adverse events.

Results Ninety-nine women with positive Candida culture remained in the modified intent-to-treat population with 40 in each CD101 arm and 19 in the fluconazole arm. In the CD101 gel, CD101 ointment, and oral fluconazole groups, 35%, 30%, and 52.6% demonstrated clinical cure and 45%, 40%, and 57.9% had mycological cure at day 28, respectively.

Conclusions CD101 3% gel and CD101 6% ointment were well tolerated and produced similar rates of clinical and mycological cure in patients with an acute, moderate-to-severe episode of VVC. However, cure rates for these 2 formulations and regimens of CD101 were lower than those in patients treated with fluconazole.

1Department of Obstetrics and Gynecology, Drexel University College of Medicine, Philadelphia, PA;

2Cidara Therapeutics, Inc, San Diego, CA; and

3Wayne State University School of Medicine, Detroit, MI

Reprint requests to: Cynthia Alessio, DO, Drexel University College of Medicine, Department of Obstetrics and Gynecology, 245 N 15th Street MS 495, Philadelphia, PA 19102. E-mail: cynthia.alessio@gmail.com; Paul Nyirjesy, MD, Drexel University College of Medicine, Department of Obstetrics and Gynecology, 245 N 15th Street MS 495, Philadelphia, PA 19102. E-mail: Pn35@drexel.edu

The study was funded by Cidara Therapeutics, San Diego, California.

P.N. received research grant funding from Cidara Therapeutics, Scynexis, Inc, and Curatek Pharmaceuticals; he has been a consultant for Symbiomix Therapeutics, Cidara Therapeutics, Scynexis, Inc, and Viamet Pharmaceuticals. A.J. is a consultant to Cidara Pharmaceuticals. T.S. is an employee of Cidara Pharmaceuticals. J.D.S. has received a research grant for Cidara and has served as a consultant to Cidara, Scynexis, Symbionix, and Viamet Pharmaceuticals. C.A. has declared she has no conflicts of interest.

This study was presented on August 10, 2017 at the Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology, Park City, UT, and on September 14, 2018 at the American College of Obstetrics and Gynecology Junior Fellows Day, Philadelphia, PA.

This study was IRB approved.

Clinical Trial Registration: Clinicaltrials.gov, https://clinicaltrials.gov/ct2/show/NCT02733432?term=cidara&rank=3, registration NCT02733432.

Online date: March 20, 2019

Copyright © 2019 by the American Society for Colposcopy and Cervical Pathology