Vulvar Atrophy, Vulvar Lichen Sclerosus
Conditions
Keywords
Lichen Sclerosus, Regenerative Medicine, Collagen Peptides, Vulvar Dryness, Hyaluronic Acid, Sexual Function
Brief summary
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
PROCEDUREAutologous 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_SUPPLEMENTCollagendep 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.
Sponsors
San Gallicano Dermatological Institute IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study; both the investigators and the participants are aware of the treatment being administered.
Intervention model description
Randomized, single-center, two-arm clinical study comparing fat grafting alone versus fat grafting plus 4 months of oral supplementation with Collagendep Pink Beauty.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Vulvar Dryness | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Mucosal Hydration | Baseline (T0) and 4 months (T2) | Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration |
| Improvement in Sexual Function | 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. |
| Patient Satisfaction with Treatment | 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) |
Outcome results
None listed