Hair Regeneration in Androgenetic Alopecia

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: Minoxidil Topical; Other: Secretome from adipose-derived stem cells; Combination product: Combination of minoxidil and secretome from adipose-derived stem cells

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • RSUP Nasional Cipto Mangunkusumo
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minoxidil; The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks	Drug: Minoxidil Topical; 20 subjects received minoxidil only for the treatment of AGA
Experimental: 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	Other: Secretome from adipose-derived stem cells; 20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
Experimental: Minoxidil + Secretome; 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; 20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Dr. dr. Lili Legiawati, SpKK(K)
• Collaborators: PT. Kimia Farma (Persero) Tbk; Ministry of Education, Culture, Research, and Technology, Republic of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Skin; Minoxidil; Androgenetic alopecia; Secretome
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: 977/UN2.F1/ETIK/PPM.00.02/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No