Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
- 主要终点
- Evolution of quality of life measured by Skindex-29 index
研究概览
简要总结
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.
Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years
- •Woman with symptoms associated with LEA confirmed by histological study
- •Being 1 month without prior treatment in the affected area as a washing period
- •Availability of observation during the treatment period
- •Signature of the informed consent
排除标准
- •Acute somatic disease
- •Infection in the intervention area or active systemic infection
- •History of cancerous or precancerous lesions in the intervention area
- •In active treatment with other local treatments in the intervention area
- •Under active treatment with immunosuppressants and/or anticoagulants
- •History of allergies to blood derivatives
- •Previous diagnosis of coagulopathies
- •Regular and continuous treatment with NSAIDs
- •Positive markers for HCV, AfHBs, HIV-I/II or PT
- •Pregnancy or women of childbearing age not taking contraceptive measures
- •Lactating women
- •Treatment with monoclonal antibodies
- •Liver failure
- •Any inability to participate in the study
研究组 & 干预措施
Conventional treatment
0.05% Clobetasol propionate
干预措施: Clobetasol Propionate (Drug)
PRGF
0.05% Clobetasol propionate + PRGF
PRGF: 4 infiltrations (first two months) + topical administration (from third month)
干预措施: PRGF (Drug)
PRGF
0.05% Clobetasol propionate + PRGF
PRGF: 4 infiltrations (first two months) + topical administration (from third month)
干预措施: Clobetasol Propionate (Drug)
结局指标
主要结局
Evolution of quality of life measured by Skindex-29 index
时间窗: 8 months
Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
次要结局
- Presence of leukocyte(0 months)
- Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)(1, 3, 6 and 8 months)
- Frequency of complications(1, 3, 6 and 8 months)
- Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)(1, 3, 6 and 8 months)
- Platelet recovery(0 months)
- Frequency of recurrences at 6 and 8 months of treatment(6 and 8 months)
- Evolution of quality of life measured by Skindex-29 index(1 and 3 months)
- Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)(1, 3, 6 and 8 months)
- Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)(1, 3, 6 and 8 months)
- Platelet concentration(0 months)