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

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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.

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Clinical change of androgenetic alopecia, as determined by scoring photographs


Condition

Androgenetic Alopecia

Intervention

Platelet Rich Plasma Prep System

Study Arms / Comparison Groups

 Platelet Rich Plasma
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

June 2019

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females ≥ 18 years old and ≤55 years old

          2. Subjects are in good health as judged by the investigator.

          3. Diagnosed with by a dermatologist with moderate androgenetic alopecia.

          4. Subject is seeking treatment for androgenetic alopecia.

          5. Subject has never previously used finasteride or minoxidil or has consistently used
             finasteride or minoxidil for at least 1 year.

          6. 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:

          1. Other than androgenetic alopecia, evidence of another skin condition affecting the
             treatment area that would interfere with clinical assessments.

          2. 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.

          3. Willing to refrain from washing hair or using hair product 24 hours before and after
             treatment visits

          4. History of a clinically significant hematologic disorder as determined by the
             investigator.

          5. Subjects currently receiving anticoagulant or anti-platelet therapy.

          6. Subjects on daily Aspirin therapy for cardiovascular disease.

          7. Subjects with chronic NSAID use, unable to wean off.

          8. Subject is known to be HIV positive.

          9. History of recurrent facial or labial herpes simplex infection

         10. History of hypertrophic scars or keloids

         11. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia,
             osteogenesis imperfecta, etc.

         12. Subjects who have any requirement for the use of local or systemic steroids or other
             immunosuppressive agent

         13. Pregnant or breast feeding

         14. Uncooperative patients or patients with neurological disorders who are incapable of
             following directions or who are predictably unwilling to return for follow-up
             examinations.

         15. Subjects who are unable to understand the protocol or give informed consent.
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Murad Alam, MD, , 



Administrative Informations


NCT ID

NCT03048461

Organization ID

MA04222016


Responsible Party

Principal Investigator

Study Sponsor

Northwestern University


Study Sponsor

Murad Alam, MD, Principal Investigator, Northwestern University


Verification Date

July 2019