Secretome vs. PRP Injections for Hair Density and Growth in Androgenetic Alopecia Patients
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CT/ALP/02/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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