NCT03488108

Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women

A Randomized Controlled Trial Comparing Platelet Rich Plasma (PRP) to Minoxidil Foam for Treatment of Androgenic Alopecia in Women

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.

Detailed description

Androgenic alopecia (AGA) is a common, progressive hair loss disorder affecting both sexes with significant negative impact on social and psychological well-being. The frequency and severity increases with age, and up to 80% of men, and 50% of women are affected by AGA over the course of their lives. While men are more frequently affected, the psychological impact is likely to be high for women where the social impact of hair loss is often devastating. Current medical therapies specifically approved by the US FDA are limited to minoxidil (for men and women) and finasteride (for men only) (Varothai), but variable responses and the need for indefinite use often result in patient fatigue and suboptimal compliance. Recently, there has been interest in treatments orientated to more biologically regenerative therapies, and consequently there have been numerous studies that have demonstrated successful use for platelet rich plasma (PRP) in treating AGA. PRP contains concentrated platelet cells derived from autologous whole blood that are believed to activate a cascade of growth factors when injected into an area of poor hair growth that stimulates hair growth. In this proposal we will examine whether PRP therapy provides similar or better hair growing capacity in women compared to the conventional topical application minoxidil.

Conditions

• Alopecia

Interventions

Type	Name	Description
OTHER	Platelet Rich Plasma	Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.
DRUG	Minoxidil Foam	Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.

Timeline

• Start date: 2017-01-23
• Primary completion: 2018-05-31
• Completion: 2019-06-17
• First posted: 2018-04-04
• Last updated: 2020-04-08
• Results posted: 2020-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study