NCT03376581

Brief Summary

Platelet rich plasma (PRP) is an autologous preparation of human plasma with high concentration of platelets. Platelets release numerous growth factors, which stimulate cell proliferation and differentiation. The purpose of this research is to investigate the potential of PRP injection for treatment of hair loss. Clinical outcomes will be assessed by noninvasive techniques including dermoscopy, multiphoton microscopy, optical coherence tomography, optical Doppler tomography and multispectral imaging.

Trial Health

87
On Track

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
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 28, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

December 13, 2017

Last Update Submit

February 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hair density to measure the efficacy of treatment

    6 months

Secondary Outcomes (6)

  • Hair count (number of hairs/0.65 cm2)

    6 months

  • Terminal hair density

    6 months

  • Anagen hair percentage

    6 months

  • Telogen hair percentage

    6 months

  • Anagen/telogen ratio

    After 3 and 6 months

  • +1 more secondary outcomes

Study Arms (1)

Prospective treatment

EXPERIMENTAL
Procedure: Platelet rich plasma

Interventions

Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.

Prospective treatment

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Ability to understand and carry out instructions
  • Diagnosed with alopecia

You may not qualify if:

  • Inability to understand and.or carry out instructions
  • Pregnant women
  • Use of any topical medication (such as minoxidil or any other solution for hair growth), oral medication (finasteride, dutasteride, or antiandrogens), laser therapy, or chemotherapy, within the preceding 4 weeks.
  • Personal medical history of bleeding disorders
  • Personal medical history of platelet dysfunction syndrome
  • Anti-coagulation therapy or nonsteroidal anti-inflammatory drugs in the last 1 week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 18, 2017

Study Start

November 28, 2017

Primary Completion

February 20, 2019

Study Completion

February 20, 2019

Last Updated

February 2, 2024

Record last verified: 2024-02

Locations