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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vulvar Lichen Sclerosus; Vulvar Atrophy
• Intervention / Treatment: Procedure: Autologous Fat Grafting (Lipofilling); Dietary supplement: Collagendep Pink Beauty

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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group (Fat Grafting + Collagendep); Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus. Additionally, they will receive oral supplementation with Collagendep Pink Beauty (1 drink stick per day) for a total duration of 4 months (120 days), starting from the day of surgery (T0).	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.
Active Comparator: Control Group (Fat Grafting Only); Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus without any additional oral supplementation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of Mucosal Hydration	Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration	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.	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)	6 months (T3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)

Collaborators and Investigators

• Sponsor: San Gallicano Dermatological Institute IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lichen Sclerosus; Hyaluronic Acid; Sexual Function; Regenerative Medicine; Collagen Peptides; Vulvar Dryness
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Vulvar Diseases; Skin and Connective Tissue Diseases; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: RS 400/ISG/25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No