Hair Regeneration in Androgenetic Alopecia

Last updated: October 5, 2023
Sponsor: Dr. dr. Lili Legiawati, SpKK(K)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Male Pattern Baldness

Hair Loss

Scalp Disorders

Treatment

Combination of minoxidil and secretome from adipose-derived stem cells

Secretome from adipose-derived stem cells

Minoxidil Topical

Clinical Study ID

NCT06066827
977/UN2.F1/ETIK/PPM.00.02/2023
  • Ages 18-59
  • Male
  • Accepts Healthy Volunteers

Study 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?

Eligibility Criteria

Inclusion

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-upvisits

Exclusion

Exclusion Criteria:

  • Hair loss other than AGA, including telogen effluvium, alopecia areata,trichotillomania, secondary syphilis, systemic lupus erythematosus hair loss due tochemotherapy, autoimmune conditions, or malignancies.
  • Patients taking oral medications or vitamins aimed at increasing hair growth in thelast month
  • Patients applying topical medications aimed at increasing hair growth in the last 2weeks
  • 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

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Combination of minoxidil and secretome from adipose-derived stem cells
Phase:
Study Start date:
August 14, 2023
Estimated Completion Date:
November 30, 2023

Study 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.

Connect with a study center

  • RSUP Nasional Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta 10430
    Indonesia

    Site Not Available

  • Universitas Indonesia

    Jakarta Pusat, Jakarta 10430
    Indonesia

    Site Not Available

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