The Utility of Platelet Rich Plasma in Hair Loss

• ClinicalTrials.gov Identifier: NCT03376581
• Recruitment Status: Completed
• First Posted: December 18, 2017
• Last Update Posted: February 22, 2019
• Sponsor: University of California, Irvine
• Information provided by (Responsible Party): Margit Juhasz, MD, University of California, Irvine

Study Description

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 Design

• 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
• Actual Primary Completion Date: February 20, 2019
• Actual Study Completion Date: February 20, 2019

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 95 Years (Adult, Older Adult)
• 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.

Contacts and Locations

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

More Information

• 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
• Last Update Posted: February 22, 2019
• Last Verified: February 2019

• 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