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| Name | Class |
|---|---|
| Ministry of Education, Culture, Research, and Technology, Republic of Indonesia | UNKNOWN |
| PT. Kimia Farma (Persero) Tbk | INDUSTRY |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minoxidil | Experimental | The 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 | Experimental | Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study |
|
| Minoxidil + Secretome | Experimental | The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil Topical | Drug | 20 subjects received minoxidil only for the treatment of AGA |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | The patient satisfaction scale using a linear analog scale with a scale of 1-7 (1 = no result, 7 = very satisfactory outcome) and was evaluated at the last treatment session. | Week 12 (end of trial) |
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Inclusion Criteria:
Exclusion Criteria:
Adult
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUP Nasional Cipto Mangunkusumo | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia | ||
| Universitas Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40021536 | Derived | 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. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
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This study was a single-blind clinical trial, masking the investigator and outcomes assessor
| Secretome from adipose-derived stem cells |
| Other |
20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA |
|
| Combination of minoxidil and secretome from adipose-derived stem cells | Combination Product | 20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA |
|
| Jakarta Pusat |
| Jakarta Special Capital Region |
| 10430 |
| Indonesia |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |