Back to resultsThe Utility of Platelet Rich Plasma in Hair Loss
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Ability to understand and carry out instructions
- Diagnosed with alopecia
Exclusion Criteria:
- 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.
Sites / Locations
- University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prospective treatment
Arm Description
Outcomes
Primary Outcome Measures
Hair density to measure the efficacy of treatment
Secondary Outcome Measures
Hair count (number of hairs/0.65 cm2)
Terminal hair density
Anagen hair percentage
Telogen hair percentage
Anagen/telogen ratio
Changes in hair structure, diameter, and blood flow
As measured by optical coherence tomography
Full Information
NCT ID
NCT03376581
First Posted
December 13, 2017
Last Updated
February 20, 2019
Sponsor
University of California, Irvine
1. Study Identification
Unique Protocol Identification Number
NCT03376581
Brief Title
The Utility of Platelet Rich Plasma in Hair Loss
Official Title
The Utility of Platelet Rich Plasma in Hair Loss
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
February 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective treatment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma
Intervention Description
Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.
Primary Outcome Measure Information:
Title
Hair density to measure the efficacy of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hair count (number of hairs/0.65 cm2)
Time Frame
6 months
Title
Terminal hair density
Time Frame
6 months
Title
Anagen hair percentage
Time Frame
6 months
Title
Telogen hair percentage
Time Frame
6 months
Title
Anagen/telogen ratio
Time Frame
After 3 and 6 months
Title
Changes in hair structure, diameter, and blood flow
Description
As measured by optical coherence tomography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Over 18 years of age
Ability to understand and carry out instructions
Diagnosed with alopecia
Exclusion Criteria:
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.
Facility Information:
Facility Name
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Utility of Platelet Rich Plasma in Hair Loss
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