NCT07450625

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: San Gallicano Dermatological Institute IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lichen sclerosus is a chronic inflammatory disease primarily affecting the ano-genital area, characterized by sclerosis and tissue atrophy. Current medical treatments, such as long-term corticosteroid use, may exacerbate existing tissue atrophy. In recent decades, regenerative therapies like fat grafting (lipofilling) have shown effectiveness in improving symptoms and stabilizing the condition. This study aims to evaluate the synergistic effect of an oral formulation, Collagendep Pink Beauty, which contains hydrolysed collagen peptides (VERISOL®), extracts of Astragalus and Centella asiatica (Astrion™), low molecular weight hyaluronic acid (HyaSource® Vita Mini), and nucleotides (Ribocare®). These ingredients are intended to stimulate endogenous collagen production and exert a trophic action on the vaginal mucosa

Conditions

• Vulvar Lichen Sclerosus
• Vulvar Atrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-20
• Primary completion: 2026-08-20
• Completion: 2027-02-20
• First posted: 2026-03-04
• Last updated: 2026-03-04