Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

NCT01590238 | Completed Phase 3 Results

• 1 other identifier: 2012-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal findings of improvement of hair appearance after PRFM injection in the scalp suggest that PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density will be assessed by comparing pre- and post-treatment photographs and non-invasive measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.

Conditions

Alopecia

Keywords

alopecia

Outcome Measures

Primary Outcomes (1)

• Hair Density Change After Three Treatments

  Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.

  6 months after initial visit

Study Arms (1)

Treatment with PRFM

EXPERIMENTAL

Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.

Biological: PRFM treatment

Interventions

PRFM treatment BIOLOGICAL

Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.

Treatment with PRFM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18- 75 years old
• frontal and/or crown alopecia

You may not qualify if:

• bleeding disorder

Sponsors & Collaborators

• The New York Eye & Ear Infirmary: lead

Study Sites (1)

The New York Eye & Ear Infirmary

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anthony P Sclafani, MD
• Organization: New York Eye & Ear Infirmary

asclafani@nyee.edu

212-979-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Facial Plastic Surgery

Study Record Dates

• First Submitted: April 29, 2012
• First Posted: May 2, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 15, 2017
• Results First Posted: November 10, 2016

Record last verified: 2016-12

Locations

US (1)