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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSan Gallicano Dermatological Institute IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Autologous Fat Grafting (Lipofilling)
  • Collagendep Pink Beauty

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations