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

N/ANot Yet RecruitingNCT07450625

San Gallicano Dermatological Institute IRCCS40 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Interventions

Autologous Fat Grafting (Lipofilling)PROCEDURE

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

Collagendep Pink BeautyDIETARY_SUPPLEMENT

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients aged 18 years or older. * Clinical diagnosis of Genital Lichen Sclerosus. * Patients with a clinical indication for autologous fat grafting (lipofilling) treatment. * Ability to provide written informed consent. * Willingness to comply with the study protocol and attend all scheduled follow-up visits. Exclusion Criteria: * Presence of active local or systemic infections. * Current pregnancy or breastfeeding. * Known hypersensitivity or allergy to any of the ingredients of the study product "Collagendep Pink Beauty" (e.g., collagen, hyaluronic acid, herbal extracts). * Concurrent use of other oral supplements that might interfere with the evaluation of the study results. * Patients with oncological pathologies (malignancies) in the vulvar area. * Inability to guarantee adequate follow-up or compliance with the treatment regimen.

Outcomes

Primary Outcomes

Reduction in Vulvar Dryness

Evaluation of the efficacy of Collagendep Pink Beauty in reducing vulvar dryness. This is measured using the "Vaginal Dryness" category of the Visual Analogue Scale (VAS), where 0 represents the complete absence of the symptom and 10 represents the maximum intensity

Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)

Secondary Outcomes

Improvement of Mucosal Hydration

Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration

Time frame: Baseline (T0) and 4 months (T2)

Improvement in Sexual Function

Measured using the Female Sexual Function Index (FSFI), which assesses six domains of sexual function through 19 items (score 0-5). Higher scores indicate better sexual function.

Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3).

Patient Satisfaction with Treatment

Assessed with a single question: "How satisfied are you with the effectiveness of the treatment received?", using a 5-point Likert scale (0 = very dissatisfied; 4 = very satisfied)

Time frame: 6 months (T3)