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The Utility of Platelet Rich Plasma in Hair Loss

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ClinicalTrials.gov Identifier: NCT03376581
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Margit Juhasz, MD, University of California, Irvine

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Procedure: Platelet rich plasma Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Utility of Platelet Rich Plasma in Hair Loss
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prospective treatment Procedure: Platelet rich plasma
Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.



Primary Outcome Measures :
  1. Hair density to measure the efficacy of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Hair count (number of hairs/0.65 cm2) [ Time Frame: 6 months ]
  2. Terminal hair density [ Time Frame: 6 months ]
  3. Anagen hair percentage [ Time Frame: 6 months ]
  4. Telogen hair percentage [ Time Frame: 6 months ]
  5. Anagen/telogen ratio [ Time Frame: After 3 and 6 months ]
  6. Changes in hair structure, diameter, and blood flow [ Time Frame: 6 months ]
    As measured by optical coherence tomography



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT03376581


Locations
United States, California
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine

Responsible Party: Margit Juhasz, MD, Clinical Research Fellow, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03376581     History of Changes
Other Study ID Numbers: 2016-3239
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 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
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical