Androgenetic AlopeciaNCT06066827
Hair Regeneration in Androgenetic Alopecia
A study testing Minoxidil Topical, Secretome from adipose-derived stem cells and Combination of minoxidil and secretome from adipose-derived stem cells in people with Androgenetic Alopecia, run by Dr. dr. Lili Legiawati, SpKK(K) at 2 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil Topical, Secretome from adipose-derived stem cells and Combination of minoxidil and secretome from adipose-derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIndonesia
- Study dates
- 14 Aug 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
RSUP Nasional Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10430
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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?
Read the 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.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil Topical, Secretome from adipose-derived stem cells, Combination of minoxidil and secretome from adipose-derived stem cells
- Keywords
- Secretome, Minoxidil, Skin, Androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil TopicalDrug
20 subjects received minoxidil only for the treatment of AGA
Secretome from adipose-derived stem cellsOther
20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA
Combination of minoxidil and secretome from adipose-derived stem cellsCombination product
20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil | Experimental | The drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks Receives: Drug: Minoxidil Topical |
| Secretome from Adipose-Derived Stem Cells | Experimental | Secretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study Receives: Other: Secretome from adipose-derived stem cells |
| Minoxidil + Secretome | Experimental | The subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration Receives: Combination Product: Combination of minoxidil and secretome from adipose-derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)
Secondary outcomes (1)
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.
Measured: Week 12 (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start14 Aug 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. dr. Lili Legiawati, SpKK(K)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, PT. Kimia Farma (Persero) Tbk
- Responsible party
- Sponsor-investigator, Dr. dr. Lili Legiawati, SpKK(K), Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066827
- Sponsor's protocol ID
- 977/UN2.F1/ETIK/PPM.00.02/2023
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legiawati L, Sitohang IBS, Yusharyahya SN, Sirait SP, Novianto E, Liem IK, Kurniawati T, Putri IS, Rahmadika FD, Hakiki NP, Lauren BC. Hair regeneration in androgenetic alopecia using secretome of adipose-derived stem cells (ADSC) and minoxidil: a comparative study of three groups. Arch Dermatol Res. 2025 Mar 1;317(1):486. doi: 10.1007/s00403-025-04006-3.
PubMed 40021536
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Regeneration in Androgenetic Alopecia Using Secretome of Adipose-derived Stem Cells (ADSC) and Minoxidil: A Comparative Study of Three Groups
- ClinicalTrials.gov ID
- NCT06066827
- Acronym / sponsor ID
- 977/UN2.F1/ETIK/PPM.00.02/2023
- Conditions
- Androgenetic Alopecia
- Keywords
- Secretome, Minoxidil, Skin, Androgenetic alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. dr. Lili Legiawati, SpKK(K)University, hospital or other
- Collaborators
- Ministry of Education, Culture, Research, and Technology, Republic of Indonesia, PT. Kimia Farma (Persero) Tbk
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Each subject will receive an injection of the secretome from ADCS's, topical minoxidil, or both.
| Arm | Type | Receives |
|---|---|---|
| Minoxidil | Experimental | Drug: Minoxidil TopicalThe drug used is minoxidil 5% solutions for topical use, 1 cc, 2 times a day, every day for 12 weeks |
| Secretome from Adipose-Derived Stem Cells | Experimental | Other: Secretome from adipose-derived stem cellsSecretom concentrate of Adipose-Derived Stem Cells (ADSCs) 2cc, injected to the scalp on weeks 0, 4, and 8 of the study |
| Minoxidil + Secretome | Experimental | Combination Product: Combination of minoxidil and secretome from adipose-derived stem cellsThe subject received both minoxidil and secretome from ADSCs, with the same dosage form, dosage, frequency, and duration |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minoxidil Topical20 subjects received minoxidil only for the treatment of AGA | Drug | Minoxidil |
| Secretome from adipose-derived stem cells20 subjects received the injection of secretome from adipose-derived stem cells only for the treatment of AGA | Other | Secretome from Adipose-Derived Stem Cells |
| Combination of minoxidil and secretome from adipose-derived stem cells20 subjects received both minoxidil and injection of secretome from adipose-derived stem cells for the treatment of AGA | Combination product | Minoxidil + Secretome |
Primary outcome
Improvement of alopecia in physical examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 (%)
1 secondary outcome
Patient satisfaction
Time frame: Week 12 (end of trial)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40021536Legiawati L, Sitohang IBS, Yusharyahya SN, Sirait SP, Novianto E, Liem IK, Kurniawati T, Putri IS, Rahmadika FD, Hakiki NP, Lauren BC. Hair regeneration in androgenetic alopecia using secretome of adipose-derived stem cells (ADSC) and minoxidil: a comparative study of three groups. Arch Dermatol Res. 2025 Mar 1;317(1):486. doi: 10.1007/s00403-025-04006-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minoxidil Topical, Secretome from adipose-derived stem cells and Combination of minoxidil and secretome from adipose-derived stem cells in people with Androgenetic Alopecia, run by Dr. dr. Lili Legiawati, SpKK(K) at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of alopecia in physical examination (time frame: Week 0 (baseline), week 4 after intervention, week 8 after intervention, week 12 (end of trial)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.