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NOT YET RECRUITING
NCT07450625
NA

Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting

Sponsor: San Gallicano Dermatological Institute IRCCS

View on ClinicalTrials.gov

Summary

This randomized, interventional study evaluates the efficacy of Collagendep Pink Beauty, an oral nutritional supplement, in reducing vulvar dryness in women with Genital Lichen Sclerosus (VLS) who are undergoing fat grafting treatment. Lichen sclerosus is a chronic inflammatory condition that leads to tissue hardening, loss of elasticity, and significant symptoms such as itching, pain, and dryness, which severely impact functional and emotional well-being. While fat grafting is a recognized regenerative therapy for stabilizing the disease, this study investigates whether a 4-month course of bioactive collagen peptides and functional ingredients can further improve mucosal hydration and symptom relief compared to fat grafting alone.

Official title: Study of the Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Genital Lichen Sclerosus Treated With Fat Grafting

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-20

Completion Date

2027-02-20

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Fat Grafting (Lipofilling)

Standard regenerative surgical procedure involving the harvesting, processing, and reinjection of autologous fat into the vulvar tissues affected by Lichen Sclerosus.

DIETARY_SUPPLEMENT

Collagendep Pink Beauty

Oral nutritional supplement containing bioactive collagen peptides (VERISOL®), hyaluronic acid, nucleotides, and herbal extracts (Astrion™). Dosage: 1 stick per day for 120 days.