Trial Outcomes & Findings for Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) (NCT NCT01590238)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

6 months after initial visit

Results posted on

2017-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment With PRFM 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. 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.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With PRFM n=15 Participants Subjects with androgenetic alopecia clinically diagnosed were 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. 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.
Age, Continuous	43.2 years STANDARD_DEVIATION 18.2 • n=99 Participants
Gender Female	6 Participants n=99 Participants
Gender Male	9 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants
Hair density index measured prior to intervention	100 percent of pre treatment value STANDARD_DEVIATION 0 • n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment With PRFM n=13 Participants Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
Hair Density Change After Three Treatments	175.1 percentage of pre-treatment hair density Standard Deviation 46.8

Adverse Events

Treatment With PRFM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony P Sclafani, MD

New York Eye & Ear Infirmary

Phone: 212-979-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place