Hair Regeneration in Androgenetic Alopecia Using Secretome of Adipose-derived Stem Cells (ADSC) and Minoxidil: A Comparative Study of Three Groups
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement of alopecia in physical examination
研究概览
简要总结
This clinical trial study aims to compare the effectiveness and safety of secretome from ADSCs with minoxidil in AGA cases, to provide future reference or standard in the application of cell-based therapy and its derivatives in AGA cases. The subject of this study is androgenetic alopecia population. The main questions it aims to answer are:
- Is the secretome of ADSC's effective compared to minoxidil?
- Is the secretome of ADSC's safe compared to minoxidil?
- Is the combination of the secretome of ADSC's and minoxidil better in safety and effectiveness compared to secretome or minoxidil alone?
详细描述
This study was a single-blind clinical trial using an experimental research design on subjects with androgenetic alopecia. Variables tested in this study were the method of "treatment of AGA by administering secretome concentrate alone, compared to using minoxidil alone and with a combination of both."
Subjects were divided into 3 groups:
- 20 subjects received secretome
- 20 subjects received minoxidil
- 20 subjects received both treatments Participants will undergo history taking, and a physical examination (including vital signs, body weight, and hair pull test). Pictures of patients' head were then taken and the hair loss degree was graded using Hamilton-Norwood. Hair growth was evaluated every month starting from months 0, 1, 2, and 3. Clinical assessment of hair growth was examined through physical and supporting examinations including photography, trichoscan, and trichoscopy.
The sample size for this study was calculated with the help of G*Power version 3.1 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).
The inclusion and exclusion criteria are applied. Statistical data were analyzed using SPSS® version 21 software. On numerical data, normality analysis was carried out using the Kolmogorov-Smirnov test.
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 (Investigator, Outcomes Assessor)
盲法说明
This study was a single-blind clinical trial, masking the investigator and outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients aged 18-59 years
- •Clinical presentation of AGA with Hamilton-Norwood Grade III-VI
- •Willing to be a research subject, sign a consent form, and commit to regular follow-up visits
排除标准
- •Hair loss other than AGA, including telogen effluvium, alopecia areata, trichotillomania, secondary syphilis, systemic lupus erythematosus hair loss due to chemotherapy, autoimmune conditions, or malignancies.
- •Patients taking oral medications or vitamins aimed at increasing hair growth in the last month
- •Patients applying topical medications aimed at increasing hair growth in the last 2 weeks
- •Patients with active bacterial, viral, or fungal infections on the scalp
- •Patients undergoing AGA therapy cosmetic procedures in the form of PRP injections, laser procedures, or micro-needling in the last 3 months
研究组 & 干预措施
Minoxidil
The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks
干预措施: Minoxidil Topical (Drug)
Secretome from Adipose-Derived Stem Cells
Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study
干预措施: Secretome from adipose-derived stem cells (Other)
Minoxidil + Secretome
The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration
干预措施: Combination of minoxidil and secretome from adipose-derived stem cells (Combination Product)
结局指标
主要结局
Improvement of alopecia in physical examination
时间窗: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
The investigator conduct a scalp examination every 4 weeks until the twelfth week to measure the improvement of alopecia with Hamilton-Norwood scale
Macroscopic hair growth documented
时间窗: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
The investigator conducted documentation of the subject in 7 positions, so that the improvement of alopecia can be seen from various directions
Microscopic hair growth evaluated by Trichoscopy
时间窗: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement
Microscopic hair growth evaluated by Trichoscan
时间窗: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
The investigator use Fotofinder® medicam 1000 s video-trichoscopy (FotoFinder Systems GmbH, Germany) for quantitative measurements, such as hair rate anagen (%), hair rate telogen (%), hair rate terminal (%), and hair rate vellus (%)
次要结局
- Patient satisfaction(Week 12 (end of trial))
研究者
Dr. dr. Lili Legiawati, SpKK(K)
Principal Investigator
Indonesia University