NCT01885676撤回不适用
A Pilot Randomized, Double-blind, Placebo-controlled Clinical Trial to Obtain Preliminary Data on Efficacy and Safety in the Application of PRGF-Endoret by Mesotherapy, in the Treatment of Male and Female Androgenetic Alopecia of Over 6 Months Duration.
Biotechnology Institute IMASD4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年9月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change from baseline in Hair density at three months (number of hairs per cm2)
研究概览
简要总结
- Androgenetic alopecia (AGA) or common baldness is the most common cause of hair loss in both men and women and is caused by the action of androgens in genetically predisposed individuals.
- This clinical trial was designed to evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Androgenetic alopecia according to the following scales:
- •Men: Hamilton/Norwood Scale: grades II-VI
- •Women: Ludwig Scale grades I-II.
- •Possibility of follow-up during the study
排除标准
- •No androgenetic alopecia
- •Telogen and anagen effluvium
- •Active inflammation or infection in the intervention area
- •Presence of active systemic infections.
- •Background of cancerous or precancerous lesions.
- •Background of connective or rheumatic diseases.
- •Suffering from any serious blood disorders.
- •To have undergone treatments for alopecia in the previous 6 months.
- •Previous hair implants
- •Intake of drugs that affect hair loss.
- •Be undergoing immunosuppressive therapy and/or anticoagulants.
- •Known intolerance to mesotherapy.
- •Taking contraceptives containing cyproterone acetate.
- •Pregnancy
- •In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables.
结局指标
主要结局
Change from baseline in Hair density at three months (number of hairs per cm2)
时间窗: 3 months post-treatment
Hair density (number of hairs per cm2) will be measured for each treatment group
次要结局
- Hair Width (micrometers)(Basal, 1, 2, and 3 months post-treatment)
- Anagen/telogen ratio(Basal, 1, 2, and 3 months post-treatment)
- Terminal Hair Density(Before each one of the treatments and 1, 2 and 3 months post-treatment.)
- Vellous hair density(Basal,1, 2 and 3 months post-treatment)
研究者
研究点 (4)
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