EUCTR2021-006474-23-ES进行中（未招募）1 期
Randomized, treatment-controlled clinical trial Conventional efficacy of Plasma Rich in Factors of Growth (PRGF®) in the treatment of atrophic vulvar lichen sclerosus
BTI I MAS D S.L.0 个研究点目标入组 30 人开始时间: 2021年12月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Age> 18 years
- •- Woman with symptoms associated with LEA confirmed with histological study
- •- Spend 1 month without previous treatment in the affected area as a washing period
- •- Availability of observation during the treatment period
- •- Signature of the informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Somatic disease in acute state
- •- Infection in the area of ??intervention or active systemic infection
- •- History of cancerous or precancerous lesions in the area of
- •intervention
- •- In active treatment with other local treatments in the intervention area
- •- In active treatment with immunosuppressants and / or anticoagulants
- •- History of allergies to blood derivatives
- •- Previous diagnosis of coagulopathies
- •- Regular and continued treatment with NSAIDs
- •- Positive markers for HCV, AfHBs, HIV-I / II or TP
- •- Pregnancy or women of childbearing potential not taking contraceptive measures
- •- Lactating women
- •- Treatment with monoclonal antibodies
- •- Any inability to participate in the study
研究者
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