Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Fat Grafting + Collagendep) | Experimental | 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). |
|
| Control Group (Fat Grafting Only) | Active Comparator | Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus without any additional oral supplementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
The study evaluates the efficacy of a nutritional supplement in reducing vulvar dryness, a condition specifically affecting female genital anatomy. The target pathology, Vulvar Lichen Sclerosus, and the surgical procedure of fat grafting described in this protocol are uniquely related to female patients.
Not provided
Not provided
Not provided
Not provided
Randomized, single-center, two-arm clinical study comparing fat grafting alone versus fat grafting plus 4 months of oral supplementation with Collagendep Pink Beauty.
Not provided
Not provided
This is an open-label study; both the investigators and the participants are aware of the treatment being administered.
Not provided
| 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. |
|
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) |
| ID | Term |
|---|---|
| D007724 | Vulvar Lichen Sclerosus |
| D018459 | Lichen Sclerosus et Atrophicus |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided