Comparison of Boric Acid vs. Terconazole in Treatment of RVVC

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04208555
• Other study ID #: MS.19.09.825
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: December 2019
• Source: Mansoura University
• Contact: Hatem Abu Hashim, MD.FRCOG.PhD
• Phone: +20502300002
• Email: hatem_ah[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: May 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Drug:
• Boric Acid Vaginal Suppository
Boric acid vaginal suppository (600 mg/day) for 14 days
• Terconazole Vaginal Suppository
Terconazole 80 mg vaginal suppository daily for 6 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mycological cure rate	Negative Candida by cultures of high vaginal swabs	At day 15 of treatment