Hair Regeneration in Androgenetic Alopecia

Sponsor

Dr. dr. Lili Legiawati, SpKK(K) (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06066827

Collaborator

Ministry of Education, Culture, Research, and Technology, Republic of Indonesia (Other), PT. Kimia Farma (Persero) Tbk (Industry)

Enrollment

Locations

Arms

3.5

Anticipated Duration (Months)

Patients Per Site

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Drug: Minoxidil Topical Other: Secretome from adipose-derived stem cells Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

This study was a single-blind clinical trial, masking the investigator and outcomes assessor

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 14, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Improvement of alopecia in physical examination [Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)]
The investigator conduct a scalp examination every 4 weeks until the twelfth week to measure the improvement of alopecia with Hamilton-Norwood scale
Macroscopic hair growth documented [Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)]
The investigator conducted documentation of the subject in 7 positions, so that the improvement of alopecia can be seen from various directions
Microscopic hair growth evaluated by Trichoscopy [Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)]
Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement
Microscopic hair growth evaluated by Trichoscan [Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)]
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 (%)

Secondary Outcome Measures

Patient satisfaction [Week 12 (end of trial)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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