Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Alopecia Clinical Trial

Official title:

Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590238
• Other study ID #: 2012-1
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2012
• Last updated: April 24, 2015
• Start date: May 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2015
• Source: The New York Eye & Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18- 75 years old

• frontal and/or crown alopecia

Exclusion Criteria:

• bleeding disorder

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia

Intervention

Biological:
• PRFM treatment
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.

Locations

Country	Name	City	State
United States	The New York Eye & Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Density Change after Three Treatments	Difference in hair density index at calibrated distance from glabella in a 2 cm x 2 cm square between initial visit and 3 month follow up visit.	3 months after initial visit	No
Secondary	Hair follicular density change after three treatments	Difference in follicular density at a calibrated distance from the glabella in a 2 cm x 2 cm square measured using digital photographs taken at 3 month follow up visit and compared to pre-treatment visit.	3 months after initial treatment	No
Secondary	Hair Density Change after Treatment	Difference in hair density index at a calibrated distance from glabella in a 2 cm x 2 cm square between initial visit and 1, 2 and 6 month follow up visit.	1, 2 and 6 months after initial visit	No
Secondary	Hair follicular density change after treatment	Differences in hair follicular density at a calibrated distance from the glabella in a 2 cm x 2 cm square measured using digital photographs taken at 1,2 and 6 month follow up visit and compared to pre- treatment photographs.	1, 2 and 6 months after initial visit	No