- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429253
Secretome vs. PRP Injections for Hair Density and Growth in Androgenetic Alopecia Patients
February 17, 2026 updated by: PT. Prodia Stem Cell Indonesia
Comparative Effectiveness of Secretome Injection and Intradermal Platelet-Rich Plasma Injection on Hair Density and Terminal-to-Vellus Hair Ratio in Patients With Androgenetic Alopecia at Prof. Dr. I.G.N.G. Ngoerah General Hospital
This study aims to compare the effectiveness of secretome injection and intradermal platelet-rich plasma (PRP) injection on hair density and the terminal-to-vellus hair ratio in patients with androgenetic alopecia at Prof. Dr. I.G.N.G.
Ngoerah General Hospital.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This research is an experimental study with a randomized controlled clinical design involving two intervention groups: one receiving secretome injections and the other receiving intradermal platelet-rich plasma injections.
Evaluations are conducted by measuring hair density and the terminal-to-vellus hair ratio before and after treatment using trichoscopy/dermoscopy.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bali
-
Denpasar, Bali, Indonesia, 80113
- Recruiting
- Prof. dr. I.G.N.G. Ngoerah Central General Hospital
-
Contact:
- Dr. dr. I Gusti Nyoman Darmaputra, Sp.D.V.E., Subsp. O.B.K., FINS
- Phone Number: +628124644451
- Email: darma@skincentrebali.com
-
Principal Investigator:
- Dr. dr. I Gusti Nyoman Darmaputra, Sp.D.V.E., Subsp. O.B.K., FINS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Hamilton-Norwood grades II to VI, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
- Female patients with androgenetic alopecia, aged 25 to 59 years, with clinical presentation consistent with Ludwig grades I to III, seeking treatment at the Dermatology and Venereology Outpatient Clinic of Prof. Dr. I.G.N.G. Ngoerah General Hospital.
- Female patients who are not currently pregnant or breastfeeding.
- Patients who have discontinued anti-androgen medication and minoxidil for at least 1 month prior to the procedure.
- Patients with no known allergies to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
- Patients who are proficient in Indonesian and willing to provide written informed consent.
Exclusion Criteria:
- Participants who are unable to speak or understand Indonesian and/or are unwilling to provide written informed consent.
- Patients presenting with types of hair loss other than androgenetic alopecia.
- Patients currently undergoing therapy with 5-alpha reductase inhibitors.
- Patients who have received intradermal corticosteroid injections to the scalp within at least 6 months prior to the study.
- Patients with active infections and/or active dermatitis on the scalp.
- Patients with a known history of allergy to secretome components and/or materials used in the platelet-rich plasma (PRP) preparation process.
- History of hypertrophic scarring or blood clotting (coagulation) disorders.
- Patients unable to complete the research procedures in their entirety.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: UC-MSC Secretome
Umbilical Cord Mesenchymal Stem Cell-derived Secretome
|
UC-MSC secretome was injected intradermally into the scalp at the alopecia site, with injections spaced 1 cm apart and administered every 2 weeks for 8 weeks
|
|
Experimental: Platelet-Rich Plasma
|
The centrifuged plasma solution was injected intradermally into the scalp at the alopecia site, with 0.1 ml per injection point spaced 1 cm apart, administered every 2 weeks for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Terminal-to-Vellus Hair Ratio
Time Frame: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
|
The ratio of terminal hair (thick, pigmented hair, diameter >40 micrometer) to vellus hair (fine hair, diameter <30 micrometer) in areas of androgenetic alopecia
|
Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
|
|
Hair density
Time Frame: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
|
The number of hairs per specific scalp area was measured in hairs/cm²
|
Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
February 17, 2026
First Submitted That Met QC Criteria
February 17, 2026
First Posted (Actual)
February 24, 2026
Study Record Updates
Last Update Posted (Actual)
February 24, 2026
Last Update Submitted That Met QC Criteria
February 17, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/ALP/02/2025
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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