BLIND RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MESOTHERAPY MINOXIDIL HAIR WITH 0.5% / 2ML VERSUS PLACEBO IN THE TREATMENT OF FEMALE ANDROGENETIC ALOPECIA
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in hair density
研究概览
简要总结
This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.
- Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks.
- One group will receive 0.5%/2ml minoxidil application and a control group will receive application of placebo (saline 0.9%).
- Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before and 08 weeks after treatment as a method objective evaluation of the response
详细描述
This is a trial that aims to analyze the efficacy and safety of mesotherapy with minoxidil 0,5% versus placebo for androgenetic alopecia in female patients.
The patients and the investigators who analyzes complementary exams are blind.
- Clinical criteria, photo, 4mm biopsia, trichogram and trichoscopy are perfomed before patients are randomized into two arms :
- Group 1 (Placebo):
30 patients who will have intradermal injections in the scalp of saline 0.9% 2. Group 2 (Active Drug):
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 18 to 65 years old
- •Androgenetic Alopecia (female pattern hair loss)
排除标准
- •patients with alopecia areata or cicatricial alopecia
- •pregnancy and breastfeeding
- •have undergone any specific treatment in the last 06 months
- •use of drugs with anti-androgenic properties
- •patients with signs or symptoms of hyper-androgynism
研究组 & 干预措施
Saline
After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the placebo group, thirty women will be subjected to intradermal application (mesotherapy) of saline; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results.
干预措施: Saline (Drug)
Minoxidil 0.5% /2ml
After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the drug active group, thirty women will be subjected to intradermal application (mesotherapy) of minoxidil 0.5%/2ml; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results.
干预措施: Minoxidil (Drug)
结局指标
主要结局
Increase in hair density
时间窗: Sixteen weeks
Six weeks after the last session of mesotherapy patients will be subjected to control examinations to evaluation of results. Scalp biopsy to determine the terminal-vellus ratio, trichogram to assess the percentage of anagen hair, telogen and dystrophic and Trichoscan will be performed to see if there was improvement in hair density
次要结局
- Mesotherapy safety(six months)
研究者
Izelda Maria Carvalho Costa
Adjunct Professor
Brasilia University Hospital