Phase 3
N=15
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)
Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT01590238 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Hair Density Change After Three Treatments — 175.1 percentage of pre-treatment hair density
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PRFM treatment (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The New York Eye & Ear Infirmary
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hair Density Change After Three Treatments |
175.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- age 18- 75 years old
- frontal and/or crown alopecia
Exclusion Criteria
- bleeding disorder
Data sourced from ClinicalTrials.gov (NCT01590238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.