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Recruiting NCT07429253

Secretome vs. PRP Injections for Hair Density and Growth in Androgenetic Alopecia Patients

Phase I / Phase II Interventional Androgenetic Alopecia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secretome, Platelet-Rich Plasma (PRP) Injections.
Who it may be relevant to
Registry conditions: Androgenetic Alopecia. Basic parameters: 25 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Biological 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
  • Biological Platelet-Rich Plasma (PRP) Injections
    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

Primary outcome measures

  • 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)]
  • Hair density [Time frame: Baseline (before treatment), post-intervention (at 8 weeks), and during follow-up visits (months 3, 6, and 9)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Prof. dr. I.G.N.G. Ngoerah Central General Hospital — Denpasar

Identifiers

NCT: NCT07429253 · CT/ALP/02/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗