The Utility of Platelet Rich Plasma in Hair Loss | NCT03376581

Studies
The Utility of Platelet Rich Plasma in Hair Loss

NCT03376581

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Feb 2, 2024Actual

Enrollment

30Actual

Phase

Early Phase 1

Conditions

Androgenetic Alopecia

Interventions

Platelet rich plasma

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2017Actual

Primary Completion Date

Feb 20, 2019Actual

Completion Date

Feb 20, 2019Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 13, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2024

Last Update Posted Date

Feb 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Natasha Mesinkovska, Principal Investigator, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prospective treatment	Experimental		Procedure: Platelet rich plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet rich plasma	Procedure	Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.	Prospective treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hair density to measure the efficacy of treatment		6 months

Secondary Outcomes

Measure	Description	Time Frame
Hair count (number of hairs/0.65 cm2)		6 months
Terminal hair density		6 months
Anagen hair percentage

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall		Irvine	California	92697	United States

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided