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NCT Number: NCT07450625

Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With 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.

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Key information

Conditions

Vulvar Lichen Sclerosus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Lichen Sclerosus et Atrophicus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Urogenital Diseases Vulvar Atrophy Vulvar Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Beauty

Dietary Supplement

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

Primary outcomes

  1. Reduction in Vulvar Dryness

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

    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

Secondary outcomes

  1. Improvement of Mucosal Hydration

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

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

  2. Improvement in Sexual Function

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

    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.

  3. Patient Satisfaction with Treatment

    Time frame: 6 months (T3)

    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)

Other outcomes

  1. Reduction of Clinical Symptoms

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

    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

Sponsors and collaborators

Lead sponsor

San Gallicano Dermatological Institute IRCCS

Other

Registry information

Official study title

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

Acronym: Collagendep

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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