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Not yet recruiting NCT07450625

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

No phase Interventional Vulvar Lichen Sclerosus Vulvar Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Fat Grafting (Lipofilling), Collagendep Pink Beauty.
Who it may be relevant to
Registry conditions: Vulvar Lichen Sclerosus, Vulvar Atrophy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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

Interventions

  • 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.

Primary outcome measures

  • Reduction in Vulvar Dryness [Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)]
Secondary outcome measures (3)
  • Improvement of Mucosal Hydration [Time frame: Baseline (T0) and 4 months (T2)]
  • Improvement in Sexual Function [Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3).]
  • Patient Satisfaction with Treatment [Time frame: 6 months (T3)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07450625 · RS 400/ISG/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗