Hair Regeneration in Androgenetic Alopecia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-14

Study Completion Date

2023-11-30

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?

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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.

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

This study was a single-blind clinical trial, masking the investigator and outcomes assessor

Study Groups

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Minoxidil

The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks

Group Type EXPERIMENTAL

Minoxidil Topical

Intervention Type DRUG

20 subjects received minoxidil only for the treatment of AGA

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

Group Type EXPERIMENTAL

Secretome from adipose-derived stem cells

Intervention Type OTHER

20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA

Minoxidil + Secretome

The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration

Group Type EXPERIMENTAL

Combination of minoxidil and secretome from adipose-derived stem cells

Intervention Type COMBINATION_PRODUCT

20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA

Interventions

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Minoxidil Topical

20 subjects received minoxidil only for the treatment of AGA

Intervention Type DRUG

Secretome from adipose-derived stem cells

20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA

Intervention Type OTHER

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

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes