Alopecia
Conditions
Keywords
alopecia
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.
Interventions
BIOLOGICALPRFM 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.
Sponsors
The New York Eye & Ear Infirmary
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18- 75 years old * frontal and/or crown alopecia
Exclusion criteria
* bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With PRFM 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Treatment With PRFM |
|---|---|
| Age, Continuous | 43.2 years STANDARD_DEVIATION 18.2 |
| Gender Female | 6 Participants |
| Gender Male | 9 Participants |
| Hair density index measured prior to intervention | 100 percent of pre treatment value STANDARD_DEVIATION 0 |
| Region of Enrollment United States | 15 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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.
Time frame: 6 months after initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment With PRFM | Hair Density Change After Three Treatments | 175.1 percentage of pre-treatment hair density | Standard Deviation 46.8 |