NCT02999737

Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for Management of Androgenic Alopecia

Evaluating the Efficacy of Different Platelet Rich Plasma (PRP) Treatment Regimens in the Management of Androgenetic Alopecia: an Investigator-initiated, Single-center, Single-blinded, Prospective, Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Skin Care and Laser Physicians of Beverly Hills · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The injection of autologous platelet rich plasma (PRP) is a relatively novel therapy, generating interest across a wide variety of medical specialties, such as orthopedics, dentistry, ophthalmology, and dermatology. Several recently published studies have demonstrated efficacy in treating androgenetic alopecia (aka male or female patterned hair loss), but each varies in the treatment protocol, and there is no evidence-based data to date guiding the dosing parameters of and intervals between injection sessions. We propose a single-center, single-blinded randomized pilot trial to investigate the most beneficial number and frequency ('schedule') of necessary PRP injections in men and women with androgenetic alopecia.

Detailed description

Androgenetic alopecia is the most common form of hair loss, affecting up to 50% of men and 21 million women in the US alone. Irrespective of gender, balding is known to influence social interactions and cause substantial emotional distress, especially for those who begin losing their hair at an early age. Topical minoxidil and oral finasteride are currently the only Food and Drug Administration (FDA)-approved therapies for androgenetic alopecia in men, and oral agents are used off-label in women but are contraindicated during pregnancy and lactation. Response to these therapies varies, and they require continued use to maintain the benefits. Hair transplantation surgery is a more permanent, yet costly, solution. All of these treatments carry a risk of undesirable side effects, so there is demand for innovative new therapeutic options. Autologous platelet rich plasma (PRP) injection is a novel therapy for the treatment of patterned hair loss, but no studies to date evaluate different treatment protocols head-to-head. Hence, the purpose of this study is to compare the efficacy of two different PRP treatment schedules (frequency and number of injection sessions) in men and women with androgenetic alopecia.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
BIOLOGICAL	Platelet Rich Plasma for 4 sessions	Injection of autologous platelet rich plasma into areas of alopecia on the scalp every month x 3 sessions then every 3 months x 1 session (total 4 sessions)
BIOLOGICAL	Platelet rich plasma for 2 sessions	Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-12-21
• Last updated: 2017-01-12

Locations

1 site across 1 country: United States