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The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Platelet Rich Plasma Prep System

Placebo

About this trial

This is an interventional treatment trial for Androgenetic Alopecia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males or females ≥ 18 years old and ≤55 years old
Subjects are in good health as judged by the investigator.
Diagnosed with by a dermatologist with moderate androgenetic alopecia.
Subject is seeking treatment for androgenetic alopecia.
Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.

Exclusion Criteria:

Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
History of a clinically significant hematologic disorder as determined by the investigator.
Subjects currently receiving anticoagulant or anti-platelet therapy.
Subjects on daily Aspirin therapy for cardiovascular disease.
Subjects with chronic NSAID use, unable to wean off.
Subject is known to be HIV positive.
History of recurrent facial or labial herpes simplex infection
History of hypertrophic scars or keloids
Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc.
Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
Pregnant or breast feeding
Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
Subjects who are unable to understand the protocol or give informed consent.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Platelet Rich Plasma

Placebo (sterile saline)

Arm Description

Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart

Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart

Outcomes

Primary Outcome Measures

Clinical change of androgenetic alopecia, as determined by scoring photographs

Secondary Outcome Measures

Full Information

NCT ID

NCT03048461

First Posted

February 7, 2017

Last Updated

December 22, 2021

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT03048461

Brief Title

The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

Official Title

A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Did not want to enroll and proceed with this study concept.

Study Start Date

June 2019 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the effect of autologous platelet-rich plasma (PRP) in the treatment of androgenetic alopecia. This is a randomized clinical trial to evaluate the effect of autologous platelet rich plasma in subjects with moderate androgenetic alopecia. Approximately 30 subjects will be randomized into the study. The study is designed as an 18-month study consisting of 2 phases. This study was a pilot study designed to determine feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

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

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet Rich Plasma

Arm Type

Experimental

Arm Description

Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart

Arm Title

Placebo (sterile saline)

Arm Type

Placebo Comparator

Arm Description

Participants will receive intradermal injections of sterile normal saline to an area (100cm2) of alopecia on the scalp. Two treatments will be performed 3 months apart

Intervention Type

Device

Intervention Name(s)

Platelet Rich Plasma Prep System

Intervention Description

intradermal injections of platelet rich plasma to an area of alopecia

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

intradermal injections to an area of alopecia

Primary Outcome Measure Information:

Title

Clinical change of androgenetic alopecia, as determined by scoring photographs

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females ≥ 18 years old and ≤55 years old Subjects are in good health as judged by the investigator. Diagnosed with by a dermatologist with moderate androgenetic alopecia. Subject is seeking treatment for androgenetic alopecia. Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator. Exclusion Criteria: Other than androgenetic alopecia, evidence of another skin condition affecting the treatment area that would interfere with clinical assessments. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study. Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits History of a clinically significant hematologic disorder as determined by the investigator. Subjects currently receiving anticoagulant or anti-platelet therapy. Subjects on daily Aspirin therapy for cardiovascular disease. Subjects with chronic NSAID use, unable to wean off. Subject is known to be HIV positive. History of recurrent facial or labial herpes simplex infection History of hypertrophic scars or keloids Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, etc. Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent Pregnant or breast feeding Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations. Subjects who are unable to understand the protocol or give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murad Alam, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia

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