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Completed

NCT Number: NCT05296863

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia

This study investigated the efficacy of adipose derived stem cell conditioned media (ADSC-CM) combined with minoxidil for hair regeneration therapy in male AGA.

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Key information

Age range

25 year–58 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

This study was a double-blind, randomized clinical trial (RCT). Two concentrations of ADSC-CM were utilized: concentrated and non-concentrated ADSC-CM. The scalp was divided vertically in half; one side was injected with 2 ml of ADSC-CM, while the control side received 2 ml of NaCl 0,9%. After the injection, patients applied topical 5% minoxidil twice daily. Clinical improvements were assessed using photographic evaluation and trichoscan every two weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males aged 25-58 years old
  • Hamilton-Norwood criteria grades II to VI
  • cessation of anti-androgens and minoxidil treatment for at least one month

Exclusion criteria

  • patients with hair loss other than AGA, such as alopecia areata, chemotherapy-induced alopecia, autoimmune-induced alopecia, and scalp malignancies;
  • patients receiving 5-alpha reductase inhibitor therapy;
  • patients who had received growth factor treatment (platelet-rich plasma or microneedling) for at least six months prior to the study; and
  • history of hypertrophic scars or blood clotting disorders.

Treatment and study plan

Non-concentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Combination Product

Non-concentrated ADSC-CM is given during week 0, 2, 4, and 6 on the left side of the scalp.

Minoxidil is applied twice using a spray, in the morning and at night.

Concentrated adipose-derived stem cell conditioned media and 5% Minoxidil

Combination Product

Intervention is given during week 0, 2, 4, and 6 on the left side of the scalp. Minoxidil is applied twice using a spray, in the morning and at night.

Placebo and 5% Minoxidil

Combination Product

Intervention is given during week 0, 2, 4, and 6 on the right side of the scalp.

Minoxidil is applied twice using a spray, in the morning and at night.

Primary outcomes

  1. Hair count

    Time frame: Within 6 weeks

    Sum of hair

  2. Hair density

    Time frame: Within 6 weeks

    count/cm2

  3. Terminal rate

    Time frame: Within 6 weeks

    Percentage of terminal hairs

  4. Vellus rate

    Time frame: Within 6 weeks

    Percentage of terminal hairs

  5. Mean thickness

    Time frame: Within 6 weeks

    In centimeters

  6. Total follicular units

    Time frame: Within 6 weeks

    Unit of hair follicles

Secondary outcomes

  1. 7-point scale

    Time frame: Within 6 weeks

    In order to assess patient satisfaction of the research process and treatment outcome

Sponsors and collaborators

Lead sponsor

Dr. dr. Lili Legiawati, SpKK(K)

Other

Collaborators

  • Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
  • PT. Kimia Farma (Persero) Tbk

Registry information

Official study title

Adipose-derived Stem Cell Conditioned Media as a Novel Approach for Hair Regrowth in Male Androgenetic Alopecia: A Randomized, Double-blind Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2022
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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