Hair Regeneration in Androgenetic Alopecia
1 other identifier
interventional
60
1 country
2
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2023
CompletedFirst Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedOctober 10, 2023
October 1, 2023
4 months
September 28, 2023
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Improvement of alopecia in physical examination
The investigator conduct a scalp examination every 4 weeks until the twelfth week to measure the improvement of alopecia with Hamilton-Norwood scale
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Macroscopic hair growth documented
The investigator conducted documentation of the subject in 7 positions, so that the improvement of alopecia can be seen from various directions
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Microscopic hair growth evaluated by Trichoscopy
Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Microscopic hair growth evaluated by Trichoscan
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 (%)
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Secondary Outcomes (1)
Patient satisfaction
Week 12 (end of trial)
Study Arms (3)
Minoxidil
EXPERIMENTALThe drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks
Secretome from Adipose-Derived Stem Cells
EXPERIMENTALSecretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study
Minoxidil + Secretome
EXPERIMENTALThe subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration
Interventions
20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
RSUP Nasional Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia
Related Publications (1)
Legiawati L, Sitohang IBS, Yusharyahya SN, Sirait SP, Novianto E, Liem IK, Kurniawati T, Putri IS, Rahmadika FD, Hakiki NP, Lauren BC. Hair regeneration in androgenetic alopecia using secretome of adipose-derived stem cells (ADSC) and minoxidil: a comparative study of three groups. Arch Dermatol Res. 2025 Mar 1;317(1):486. doi: 10.1007/s00403-025-04006-3.
PMID: 40021536DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This study was a single-blind clinical trial, masking the investigator and outcomes assessor
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 4, 2023
Study Start
August 14, 2023
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share