NCT05012852

Evaluation of VagiVitalAC for Treatment of Candida Vulvovaginitis

A Two-part Study; Consisting of a Pilot Part Followed by a Randomized, Parallel Group Part; Comparing Topically Applied Novel Gel Containing Lactic Acid With no Treatment on Women With Candida Vulvovaginitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: PepTonic Medical AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Candidiasis is an infection caused by a yeast (a type of fungus) called Candida. Candidiasis in the vagina is commonly called a "vaginal yeast infection." Another names for this infection is "vaginal candidiasis". The symptoms of vaginal candidiasis include: Vaginal itching or soreness, Pain during sexual intercourse, Pain or discomfort when urinating and Abnormal vaginal discharge. VagiVitalAC is a modified version of the existing gel VagiVital, formulated to act as a treatment for fungal infections. This clinical investigation is a two-part study consisting of a pilot part followed by a randomized part. The aim of the pilot part is to evaluate if VagiVitalAC is able to cure the vulvovaginal candidiasis in at least 70% of the patients after 7 days treatment. If the proportion of cured patients is at least 70 %, the next part, the randomized part, will be performed. In the randomized part, the treatment efficacy and safety of VagiVitalAC on candida vulvovaginitis will be evaluated by comparing a treatment group with a control group receiving no treatment.

Conditions

• Vaginal Candidiasis
• Vulvovaginal Candidiasis
• Candidal Vulvovaginitis

Interventions

Type	Name	Description
DEVICE	VagiVitalAC	In the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-02-01
• Completion: 2022-06-01
• First posted: 2021-08-19
• Last updated: 2021-09-23

Locations

1 site across 1 country: Sweden