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

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ClinicalTrials.gov Identifier: NCT03048461
Recruitment Status : Not yet recruiting
First Posted : February 9, 2017
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: Platelet Rich Plasma Prep System Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Platelet Rich Plasma
Participants will receive intradermal injections autologous PRP to an area (100cm2) of alopecia on the scalp.Two treatments will be performed 3 months apart
Device: Platelet Rich Plasma Prep System
intradermal injections of platelet rich plasma to an area of alopecia

Placebo Comparator: Placebo (sterile saline)
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
Device: Platelet Rich Plasma Prep System
intradermal injections of platelet rich plasma to an area of alopecia

Drug: Placebo
intradermal injections to an area of alopecia




Primary Outcome Measures :
  1. Clinical change of androgenetic alopecia, as determined by scoring photographs [ Time Frame: Baseline to 6 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048461


Contacts
Contact: Emily Poon, PhD 312-695-4761 nufsm-dermatology@northwestern.edu
Contact: Alexandra Weil +1 312 695 6785 alexandra.weil@northwestern.edu

Locations
United States, Illinois
Northwestern University Department of Dermatology Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Michael Shalaby, MD    312-695-4761    michael.shalaby@northwestern.edu   
Principal Investigator: Murad Alam, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University

Responsible Party: Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT03048461     History of Changes
Other Study ID Numbers: MA04222016
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical