NCT03474718

Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.

Detailed description

Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory alopecia. Though the mechanism of action is not well understood, PRP is thought to promote angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The primary objective of the study is to determine whether PRP, administered once monthly for 3 months improves clinical outcomes and quality of life in females with androgenic alopecia. This is a randomized, placebo-controlled, double-blind, half-head, single center clinical study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life Quality Index will be assessed at several time points. Disease severity will be measured using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX); Trichoscan images will be captured to document participants' clinical progress. Adverse events will be recorded at each visit, treatment will be discontinued if any subject experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1 month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI, SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects with androgenic alopecia.

Conditions

• Androgenic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Platelet-rich Plasma Left Side	Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.
BIOLOGICAL	Platelet-rich Plasma Right Side	Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2018-03-22
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study