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.
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.
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.
Parallel
Autologous Fat Grafting (Lipofilling)
Procedure/SurgeryStandard regenerative surgical procedure involving the harvesting, processing, and reinjection of autologous fat into the vulvar tissues affected by Lichen Sclerosus.
Collagendep Pink Beauty
Dietary supplementOral nutritional supplement containing bioactive collagen peptides (VERISOL®), hyaluronic acid, nucleotides, and herbal extracts (Astrion™). Dosage: 1 stick per day for 120 days.
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
Improvement of Mucosal Hydration
Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration
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.
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)
Reduction of Clinical Symptoms
Assessment of the reduction of itching, burning, and pain using the Dermatology Life Quality Index (DLQI). The questionnaire consists of 10 items, each rated on a 4-point Likert scale (0-3). Higher scores indicate a greater impairment of quality of life
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