Clinical trial NCT04208555: Comparison of Boric Acid vs. Terconazole in Treatment of RVVC
Official title: A Randomized Comparison of Boric Acid Versus Terconazole in Treatment of Recurrent Vulvovaginal Candidiasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vulvovaginal Candidiasis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mycological cure rate
timeFrame: At day 15 of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Hatem Abu Hashim, MD. FRCOG. PhD
role: STUDY_CHAIR
affiliation: New Mansoura General Hospital
name: Asmaa Swidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.