Study of the Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Genital Lichen Sclerosus Treated With Fat Grafting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Reduction in Vulvar Dryness
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study; both the investigators and the participants are aware of the treatment being administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group (Fat Grafting + Collagendep)
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).
干预措施: Autologous Fat Grafting (Lipofilling) (Procedure)
Intervention Group (Fat Grafting + Collagendep)
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).
干预措施: Collagendep Pink Beauty (Dietary Supplement)
Control Group (Fat Grafting Only)
Patients in this arm will undergo the standard surgical procedure of autologous fat grafting (lipofilling) for Genital Lichen Sclerosus without any additional oral supplementation.
干预措施: Autologous Fat Grafting (Lipofilling) (Procedure)
结局指标
主要结局
Reduction in Vulvar Dryness
时间窗: 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
次要结局
- 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))