VALOR: Vaginal Atrophy & Long-term Observation of Recovery Using 7-0940 Gel Dressing

What this Trial Is About

Researchers are studying vulvovaginal skin conditions such as vaginal atrophy, lichen sclerosus, lichen simplex chronicus, and lichen planus in adult women. The study aims to evaluate the short- and long-term safety and effectiveness of a new gel dressing device designed to support vulvovaginal mucosal health and promote recovery after vaginal rejuvenation. The investigational treatment being assessed is a non-hormonal, non-steroidal gel called 7-0940. This gel is intended to relieve symptoms like itchiness, dryness, burning, painful intercourse, and tenderness while improving skin conditions such as erythema and tissue thinning. The gel supports a moist healing environment to speed up tissue repair and is intended for long-term use without the side effects associated with hormonal or corticosteroid therapies. Participants will be observed over a 12-month period where researchers will measure changes in symptom scores, quality of life, and clinical signs using questionnaires and rating scales. Safety will be monitored by tracking adverse reactions and treatment adherence. The study involves using digital devices like smartphones or computers for communication and data collection. Total participation duration and detailed assessments are planned to understand the gel's impact on vulvovaginal health over time.

VALOR: Vaginal Atrophy & Long-term Observation of Recovery