Hair Regeneration in Androgenetic Alopecia

Study Overview
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Brief Summary
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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: 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
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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.

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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: Minoxidil Topical
* Other: Secretome from adipose-derived stem cells
* Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minoxidil<br>The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks | Drug: Minoxidil Topical<br>* 20 subjects received minoxidil only for the treatment of AGA<br>|
| Experimental: Secretome from Adipose-Derived Stem Cells<br>Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study | Other: Secretome from adipose-derived stem cells<br>* 20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA<br>|
| Experimental: Minoxidil + Secretome<br>The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration | Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells<br>* 20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secretome, Minoxidil, Skin, Androgenetic alopecia