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

NCT07450625 | Not Yet Recruiting

• 1 other identifier: RS 400/ISG/25
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvar Lichen Sclerosus; Vulvar Atrophy

Keywords

Lichen Sclerosus; Regenerative Medicine; Collagen Peptides; Vulvar Dryness; Hyaluronic Acid; Sexual Function

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Improvement of Mucosal Hydration

  Baseline (T0) and 4 months (T2)

• Improvement in Sexual Function

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

• Patient Satisfaction with Treatment

  6 months (T3)

Other Outcomes (1)

• Reduction of Clinical Symptoms

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

Study Arms (2)

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).

Procedure: Autologous Fat Grafting (Lipofilling); Dietary Supplement: Collagendep Pink Beauty

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.

Procedure: Autologous Fat Grafting (Lipofilling)

Interventions

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.

Control Group (Fat Grafting Only); Intervention Group (Fat Grafting + Collagendep)

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.

Intervention Group (Fat Grafting + Collagendep)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Gallicano Dermatological Institute IRCCS: lead

MeSH Terms

Conditions

Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; both the investigators and the participants are aware of the treatment being administered.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, single-center, two-arm clinical study comparing fat grafting alone versus fat grafting plus 4 months of oral supplementation with Collagendep Pink Beauty.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02