NCT07739147

Brief Summary

The goal of this clinical trial is to compare 3 different types of PRP in androgenetic alopecia patients. The main questions it aims to answer: Does Redlight enhanced, Blue light enhanced, or traditional PRP result in higher hair density and health? Does Redlight enhanced, Blue light enhanced, or traditional PRP result in other improved hair metrics. Participants will consent to a PRP treatment but will be blinded to the type. They will then be asked to return for Tricholab analysis at set post-operative timepoints to record changes in hair metrics (Baseline, 1 month, 3 months, 6 months, 9 months, 12 months).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
12mo left

Started Dec 2026

Shorter than P25 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

December 30, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Androgenetic AlopeciaHairlossTrichoscopyplatelet-rich plasma

Outcome Measures

Primary Outcomes (2)

  • Hair rate Terminal/Vellus (%)

    Taken from TrichoLab Trichoscopy

    Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months

  • Hair Density (N/cm^2)

    Taken from TrichoLab Trichoscopy

    Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months

Secondary Outcomes (3)

  • Hair Density Terminal and Vellus (N/cm^2)

    Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months

  • Mean Thickness (um)

    Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months

  • Cumulative Hair Thickness (mm/cm^2)

    Trichoscopy taken at baseline, 1 month, 2 months, 6 months, 9 months, 12 months

Study Arms (3)

Standard PRP

EXPERIMENTAL

Participants assigned to this arm receive autologous PRP injection alone, prepared from their own peripherally drawn injected into the scalp. No adjunctive light therapy or cooling is applied in this arm. (Intervention 1 only)

Drug: Platelet-Rich Plasma (PRP) Injections

Red-Light Enhanced PRP

EXPERIMENTAL

Participants assigned to this arm receive autologous PRP injection, prepared and administered as Arm 1, immediately followed by red-light photobiomodulation therapy delivered via the MetaCell Technologies System, combined with cooling. (Intervention 1 and 2)

Drug: Platelet-Rich Plasma (PRP) InjectionsDevice: Red-light photobiomodulation with cooling

Blue-Light Enhanced PRP

EXPERIMENTAL

Participants assigned to this arm receive autologous PRP injection, prepared and administered as intervention 1, immediately followed by blue-light photobiomodulation therapy delivered via the MetaCell Technologies System with heating. (Intervention 1 and 3)

Drug: Platelet-Rich Plasma (PRP) InjectionsDevice: Blue-light photobiomodulation

Interventions

Autologous platelet-rich plasma prepared from the participant's own peripherally drawn. Blood is processed via centrifugation to concentrate platelets and associated growth factors, then injected into the scalp across the area of hair thinning. Administered at each treatment visit per the study treatment schedule.

Blue-Light Enhanced PRPRed-Light Enhanced PRPStandard PRP

Standard Intervention 1 with PRP undergoing additional Stimulus 1: 620 nm, 1 J/cm², 10 minutes; Stimulus 2: 4°C cooling, 15 minutes via MetaCell Technologies System.

Red-Light Enhanced PRP

Standard Intervention 1 with PRP undergoing additional Stimulus 1: 467 nm, 1 J/cm², 10 minutes; Stimulus 2: 37°C, 10 minutes using MetaCell Technologies System.

Blue-Light Enhanced PRP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Diagnosed Androgenetic Alopecia
  • Willing to comply with protocol and follow up

You may not qualify if:

  • Active scalp infection or disease
  • Prior PRP within last 6 months
  • Use of hair growth medication topical or oral
  • Platelet dysfunction or anticoagulation
  • Pregnant or breastfeeding
  • history of keloid infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alopecia

Interventions

Injections

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Kimberly Meathrel

    Bespoke Skin MD

    STUDY DIRECTOR

Central Study Contacts

Kimberly E Meathrel, MD, JD, MBA, MSc, FRCSC

CONTACT

Mya T Clark, BScH

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Surgeon and Principal Investigator

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

December 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07