Hair Regeneration in Androgenetic Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06066827
• Other study ID #: 977/UN2.F1/ETIK/PPM.00.02/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 14, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: October 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• Minoxidil Topical
20 subjects received minoxidil only for the treatment of AGA

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

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

Locations

Country	Name	City	State
Indonesia	RSUP Nasional Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta
Indonesia	Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (3)

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

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)