Hair Regeneration in Androgenetic Alopecia

Dr. dr. Lili Legiawati, SpKK(K)

Status: Active, not recruiting

Conditions: Androgenetic Alopecia

Treatments: Drug: Minoxidil Topical; Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells; Other: Secretome from adipose-derived stem cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06066827

977/UN2.F1/ETIK/PPM.00.02/2023

Details and patient eligibility

About

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?

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Minoxidil

Experimental group

Description:

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

Treatment:

Drug: Minoxidil Topical

Secretome from Adipose-Derived Stem Cells

Experimental group

Description:

Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study

Treatment:

Other: Secretome from adipose-derived stem cells

Minoxidil + Secretome

Experimental group

Description:

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

Treatment:

Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells