Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

A Randomized Comparison of Boric Acid Versus Terconazole in Treatment of Recurrent Vulvovaginal Candidiasis

Vulvovaginal candidiasis (VVC) caused by Candida species, predominantly C. Albicans is considered one of the most common infections of the lower female genital tract affecting 75% of women at least once in their lifetime. Recurrent VVC (RVVC) is arbitrarily defined as four or more episodes every year. RVVC is a debilitating, long-term condition that can severely affect the quality of life of women. Several factors have been associated with RVVC such as prolonged use of antibiotics, inadequately treated infection, uncontrolled diabetes, immune mechanisms (e.g. HIV), oral contraceptive use as well as the resistance of non-albicans Candida species (e.g. C glabrata, C krusei) to conventional antifungal agents as azoles.

Fluconazole administered orally is the most commonly used antifungal drug in the case of RVVC. However, in the last decade, fluconazole-resistant C Albicans has been reported in women with RVVC. Terconazole is a broad-spectrum, triazole antifungal treatment agent for both C Albicans and non-albicans. Its use (80 mg vaginal suppository daily for 6 days) was as effective as two doses of oral fluconazole (150 mg) in the treatment of patients with severe VVC and RVVC.

Boric acid or boracic [B(OH)3] is a weak acid with proven antifungal action. In RVVC especially in azole-resistant strains and in non-Candida Albicans, 600 mg of the boric acid vaginal suppository is recommended once daily for 2 weeks. This regimen has a mycologic cure rate varied from 40% to 100%. However, there are no published studies comparing the intravaginal use of boric acid with terconazole for RVVC. Accordingly, a prospective randomized study in patients with RVVC will be conducted to address this important issue.

Study Overview

• Status: Unknown
• Conditions: Vulvovaginal Candidiasis
• Intervention / Treatment: Drug: Boric Acid Vaginal Suppository; Drug: Terconazole Vaginal Suppository

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatem Abu Hashim, MD.FRCOG.PhD; Phone Number: +20502300002; Email: hatem_ah@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Diagnosis of RVVC will be defined as four or more episodes of VVC that occurred during the previous 12-month period.
• Has symptoms and signs of VVC e.g. itching, burning, discharge, and erythema.
• Documented VVC on high vaginal swabs (HVSs) by the demonstration of blastospores and pseudohyphae in a wet vaginal smear treated with 10% potassium hydroxide, and a positive fungal culture.
• Age: 18-50 years old and premenopausal.
• Agree to abstain from sexual intercourse during the treatment period.
• Agree to abstain from using any other vaginal product during the study period.

Exclusion Criteria:

• Postmenopausal.
• Pregnancy.
• Sexually transmitted infection (Chlamydia, gonorrhea, trichomonas).
• Any antifungal or antibiotic use 14 days prior to treatment.
• Gynecological conditions requiring treatment e.g. Bartholin's cyst, abscess, PID.
• Patients receiving corticosteroids or immunosuppressive therapy.
• Patients expected to menstruate within seven days of the start of treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Boric acid vaginal suppository	Drug: Boric Acid Vaginal Suppository; Boric acid vaginal suppository (600 mg/day) for 14 days
Active Comparator: Terconazole vaginal suppository	Drug: Terconazole Vaginal Suppository; Terconazole 80 mg vaginal suppository daily for 6 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological cure rate	Negative Candida by cultures of high vaginal swabs	At day 15 of treatment

Collaborators and Investigators

• Sponsor: Hatem AbuHashim
• Investigators: Principal Investigator: Asmaa Swidan, MBBCh, New Mansoura General Hospital

Publications and helpful links

General Publications

• Iavazzo C, Gkegkes ID, Zarkada IM, Falagas ME. Boric acid for recurrent vulvovaginal candidiasis: the clinical evidence. J Womens Health (Larchmt). 2011 Aug;20(8):1245-55. doi: 10.1089/jwh.2010.2708. Epub 2011 Jul 20.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): May 31, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 21, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Candidiasis, Vulvovaginal; Anti-Infective Agents; Antifungal Agents; Terconazole
• Other Study ID Numbers: MS.19.09.825

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No