An interventional study of Autologous Fat Grafting (Lipofilling) and Collagendep Pink Beauty in Vulvar Lichen Sclerosus and Vulvar Atrophy, sponsored by San Gallicano Dermatological Institute IRCCS. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by San Gallicano Dermatological Institute IRCCS · Not applicable, Interventional, and Supportive care
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
33 studies on the registry are indexed under Vulvar Lichen Sclerosus; 10 are open to participants now.
This study's planned enrollment of 40 is close to the median of 39 across 30 interventional studies indexed under Vulvar Lichen Sclerosus.
Browse Vulvar Lichen Sclerosus studies →San Gallicano Dermatological Institute IRCCS is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Dietary Supplement: Collagendep Pink Beauty
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.
Oral nutritional supplement containing bioactive collagen peptides (VERISOL®), hyaluronic acid, nucleotides, and herbal extracts (Astrion™). Dosage: 1 stick per day for 120 days.
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
Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)
Improvement of Mucosal Hydration
Measured through Trans-Epidermal Water Loss (TEWL) analysis to evaluate skin barrier integrity and mucosal hydration
Time frame: 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.
Time frame: 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)
Time frame: 6 months (T3)
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
Time frame: Baseline (T0), 2 months (T1), 4 months (T2), and 6 months (T3)
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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San Gallicano Dermatological Institute IRCCS