EUCTR2021-000865-33-ES进行中（未招募）1 期
Randomized, parallel controlled study with routine clinical practice to evaluate the efficacy and tolerability of PRFC ENDORET® in the treatment of frontal fibrosing alopecia - PRP - Fibrosing Frontal Alopecia
INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA0 个研究点目标入组 74 人开始时间: 2021年6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
- 74
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
- All
入选标准
- •Patients diagnosed with fibrosing frontal alopecia (FFA) with an age greater than or equal to 18 years.
- •Patient not responding to previous treatments for at least 6 months.
- •Use of effective physical or pharmacological contraceptive measures
- •Free acceptance to participate in the trial, with the written informed consent of the volunteer.
- •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 74
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Hematological or bleeding disorders.
- •Diagnosed platelet dysfunction.
- •Use of anticoagulant therapy or non-steroidal anti-inflammatory drugs in the 5 days prior to the extraction of the blood sample.
- •Cancer and / or treatment with chemotherapy and / or radiotherapy.
- •Topical or intralesional use of corticosteroids in the previous 4 weeks.
- •Severe or multiple allergy to medications.
- •Allergy or intolerance to any component of the study products (including peanuts and / or soybeans)
- •Hypersensitivity to calcium chloride and / or calcium citrate.
- •Patients who are immunosuppressed or who have received immunosuppressive treatment in the previous 12 weeks.
- •Presence of untreated thyroid disease.
- •Local or systemic infections.
- •Infectious processes, folliculitis, facial herpes or uncontrolled pigmentation disorders.
- •Patients undergoing chemical peeling, laser or any other type of facial treatment during the previous 6 months.
- •Any medical or psychiatric condition that makes it difficult, according to clinical judgment, to participate in the study.
- •Being participating in another research study.
- •Patients with unattainable expectations.
- •Pregnancy and / or breastfeeding.
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