A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA. The design of this small-scale, phase 1b/2a clinical trial is to demonstrate that pulsed electric field activation of autologous PRP results in a controlled release of platelet growth factors and other biologically active molecules that will have a benefit effect on the non-cycling hair follicles in the treated scalp compared to non-activated PRP. This single-center, auto-controlled study will compare the clinical benefit of PEFA-PRP versus non-activated PRP treatment of male patients with AGA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
PRP created using a commercially available system will be used for treatment. PEFA-PRP will be created by subjecting PRP to a pulsed electrical field in a specially designed instrument developed by sponsor. Two 9 cm2 contralateral regions of interest (ROI) on the scalp will be treated with approximately 6mL of either PRP or PEFA-PRP by subcutaneous injection.
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Change in hair density and hair regrowth
The change in hair density (hair count and thickness) measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. The same region on the contralateral scalp
Time frame: Month 6 and Month 8
Measurement of hair regrowth
The amount of hair regrowth measured in the region of interest (ROI) at six months and eight months using automated image analysis with Trichovision/Fotofinder imaging software. The change will be compared to the following: 1. Baseline in the same ROI 2. An entire treatment area with diagnosed AGA on the scalp 3. The same region on the contralateral scalp
Time frame: Month 6 and Month 8
Clinical progression of treatment as determined by principal investigator
Global photography evaluation by the PI using Norwood Hamilton scale.
Time frame: Month 6 and Month 8
Clinical progression of treatment as determined by subject
Change in reported patient satisfaction outcome surveys.
Time frame: Month 6 and Month 8
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