Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia: A Randomized, Double-blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Hair density
研究概览
简要总结
This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA.
详细描述
This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical improvements were assessed using photographic evaluation and trichoscan every two weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 58 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •males aged 25-58 years old
- •Hamilton-Norwood criteria grades II to VI
- •cessation of anti-androgens and minoxidil treatment for at least one month
排除标准
- •patients with hair loss other than AGA, such as alopecia areata, chemotherapy-induced alopecia, autoimmune-induced alopecia, and scalp malignancies;
- •patients receiving 5-alpha reductase inhibitor therapy;
- •patients who had received growth factor treatment (platelet-rich plasma or microneedling) for at least six months prior to the study; and
- •history of hypertrophic scars or blood clotting disorders.
研究组 & 干预措施
Non-concentrated ADSC-CM
2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
干预措施: Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil (Combination Product)
Non-concentrated ADSC-CM
2 ml intradermal injection of non-concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
干预措施: Placebo and 5% Minoxidil (Combination Product)
Concentrated ADSC-CM
2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
干预措施: Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil (Combination Product)
Concentrated ADSC-CM
2 ml intradermal injection of concentrated ADSC-CM + 1 ml of 5% topical Minoxidil daily
干预措施: Placebo and 5% Minoxidil (Combination Product)
结局指标
主要结局
Hair density
时间窗: Within 6 weeks
count/cm2
Terminal rate
时间窗: Within 6 weeks
Percentage of terminal hairs
Vellus rate
时间窗: Within 6 weeks
Percentage of terminal hairs
Total follicular units
时间窗: Within 6 weeks
Unit of hair follicles
Mean thickness
时间窗: Within 6 weeks
In centimeters
Hair count
时间窗: Within 6 weeks
Sum of hair
次要结局
- 7-point scale(Within 6 weeks)
研究者
Dr. dr. Lili Legiawati, SpKK(K)
Principal Investigator
Indonesia University