NCT06066827

Hair Regeneration in Androgenetic Alopecia

Hair Regeneration in Androgenetic Alopecia Using Secretome of Adipose-derived Stem Cells (ADSC) and Minoxidil: A Comparative Study of Three Groups

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dr. dr. Lili Legiawati, SpKK(K) · Academic / Other
• Sex: Male
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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?

Detailed description

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DRUG	Minoxidil Topical	20 subjects received minoxidil only for the treatment of AGA
OTHER	Secretome from adipose-derived stem cells	20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
COMBINATION_PRODUCT	Combination of minoxidil and secretome from adipose-derived stem cells	20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA

Timeline

• Start date: 2023-08-14
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2023-10-04
• Last updated: 2023-10-10

Locations

2 sites across 1 country: Indonesia