Comparing Different Platelet Rich Plasma (PRP) Treatment Regimens for

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02999737
Study type	Interventional
Source	Skin Care and Laser Physicians of Beverly Hills
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	November 2016
Completion date	August 2017

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT06239207` - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia	Phase 2
Completed	`NCT04945226` - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001	Phase 1/Phase 2
Completed	`NCT01437163` - Treatment of Androgenetic Alopecia in Males and Females	N/A
Completed	`NCT01548066` - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss	Phase 2
Completed	`NCT01226459` - Clinical Trial in Females for Female Pattern Hair Loss	Phase 3
Recruiting	`NCT06118866` - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia	Phase 2
Completed	`NCT06149221` - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss	N/A
Withdrawn	`NCT04882969` - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia	N/A
Completed	`NCT01231607` - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia	Phase 3
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Completed	`NCT02729415` - Point-of-Care Adipose-derived Cells for Hair Growth	N/A
Completed	`NCT02279823` - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia	Phase 2
Not yet recruiting	`NCT01227031` - Pharmacogenomic Study of Androgenetic Alopecia	N/A
Completed	`NCT00981461` - Treatment of Androgenetic Alopecia in Females, 9 Beam	N/A
Completed	`NCT01451021` - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss	Phase 2
Completed	`NCT00151515` - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss	Phase 3
Completed	`NCT03694067` - Androgenetic Alopecia and the JAK-STAT Pathway
Completed	`NCT03689452` - The Effect of Platelet Rich Plasma on Non-scarring Alopecia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms