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Hair Regeneration in Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Active
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Minoxidil Topical
Secretome from adipose-derived stem cells
Combination of minoxidil and secretome from adipose-derived stem cells
Sponsored by
Dr. dr. Lili Legiawati, SpKK(K)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Secretome, Minoxidil, Skin, Androgenetic alopecia

Eligibility Criteria

18 Years - 59 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • RSUP Nasional Cipto Mangunkusumo
  • Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Minoxidil

Secretome from Adipose-Derived Stem Cells

Minoxidil + Secretome

Arm Description

The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks

Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study

The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration

Outcomes

Primary Outcome Measures

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
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
Microscopic hair growth evaluated by Trichoscopy
Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement
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 (%)

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2023
Last Updated
October 5, 2023
Sponsor
Dr. dr. Lili Legiawati, SpKK(K)
Collaborators
Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, PT. Kimia Farma (Persero) Tbk
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1. Study Identification

Unique Protocol Identification Number
NCT06066827
Brief Title
Hair Regeneration in Androgenetic Alopecia
Official Title
Hair Regeneration in Androgenetic Alopecia Using Secretome of Adipose-derived Stem Cells (ADSC) and Minoxidil: A Comparative Study of Three Groups
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. dr. Lili Legiawati, SpKK(K)
Collaborators
Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, PT. Kimia Farma (Persero) Tbk

4. Oversight

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
Data Monitoring Committee
Yes

5. 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Secretome, Minoxidil, Skin, Androgenetic alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
Masking
InvestigatorOutcomes Assessor
Masking Description
This study was a single-blind clinical trial, masking the investigator and outcomes assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minoxidil
Arm Type
Experimental
Arm Description
The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks
Arm Title
Secretome from Adipose-Derived Stem Cells
Arm Type
Experimental
Arm Description
Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study
Arm Title
Minoxidil + Secretome
Arm Type
Experimental
Arm Description
The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration
Intervention Type
Drug
Intervention Name(s)
Minoxidil Topical
Intervention Description
20 subjects received minoxidil only for the treatment of AGA
Intervention Type
Other
Intervention Name(s)
Secretome from adipose-derived stem cells
Intervention Description
20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
Intervention Type
Combination Product
Intervention Name(s)
Combination of minoxidil and secretome from adipose-derived stem cells
Intervention Description
20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA
Primary Outcome Measure Information:
Title
Improvement of alopecia in physical examination
Description
The investigator conduct a scalp examination every 4 weeks until the twelfth week to measure the improvement of alopecia with Hamilton-Norwood scale
Time Frame
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Title
Macroscopic hair growth documented
Description
The investigator conducted documentation of the subject in 7 positions, so that the improvement of alopecia can be seen from various directions
Time Frame
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Title
Microscopic hair growth evaluated by Trichoscopy
Description
Microscopic hair growth was documented using Heine® Delta 20 Plus (Heine, Germany) dermoscopy for qualitative measurement
Time Frame
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Title
Microscopic hair growth evaluated by Trichoscan
Description
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 (%)
Time Frame
Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
Week 12 (end of trial)

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Adult
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
RSUP Nasional Cipto Mangunkusumo
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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Hair Regeneration in Androgenetic Alopecia

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