Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Phase 3

Completed

• Conditions: Alopecia
• Interventions: Biological: PRFM treatment

• Registration Number: NCT01590238
• Lead Sponsor: The New York Eye & Ear Infirmary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-29
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-02
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Results First Submitted: 2016-09-22
• Results First Submitted QC: 2016-09-22
• Results First Posted: 2016-11-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-29
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with PRFM	PRFM treatment	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.

Primary Outcome Measures

Name	Time	Method
Hair Density Change After Three Treatments	6 months after initial visit	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.

Trial Locations

Locations (1)

The New York Eye & Ear Infirmary; 🇺🇸 New York, New York, United States