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

Phase 1

Completed

Conditions: Alopecia

Interventions: Other: Platelet Rich Plasma
Drug: Minoxidil Foam

Registration Number: NCT03488108

Lead Sponsor: Mayo Clinic

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 20

Inclusion Criteria

Only female patients are eligible
Patients must be 18 years of age or older
Patients must have Androgenic Alopecia Grade I-II by Ludwig Classification
Patients must have been on stable birth control if premenopausal.
Patients are able and willing to provide written informed consent after the nature of the study is fully explained

Exclusion Criteria

Patients with clinically abnormal hematology, serum chemistry, or screening laboratory results as reviewed by the Principal Investigator
Patients who have undergone topical and systemic therapies for hair loss 3 months prior to the procedure
Patients who have used any cosmetic product meant to address hair loss 3 months prior to enrollment
Patients taking anti-rheumatic disease medication (including methotrexate or other anti-metabolites) within the 3 months prior to study entry.
Patients previously having undergone hair transplant surgery prior to study entry
Patients who are pregnant or currently breast-feeding children as Rogaine for Women is contra indicated for these women
Patients who have taken spironolactone in the 3 months prior to study participation
Patients with systemic, rheumatic or inflammatory disease or who are immunosuppressed
Patients with ongoing infectious disease, including HIV and hepatitis
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
Patients participating in a study of an experimental drug or medical device within 30 days of study entry
Patients with history of platelet disorders, bone marrow aplasia, sepsis, or cancer in the last 5 years.
Patients taking antiaggregating therapy
Patients on anticoagulant therapy
Patients with tendency to keloid formation
Patients with uncompensated diabetes
Patients with active skin disease or skin infection at intended treatment areas

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma first, then Minoxidil Foam	Minoxidil Foam	Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.
Minoxidil Foam first, then Platelet Rich Plasma	Platelet Rich Plasma	Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.
Platelet Rich Plasma first, then Minoxidil Foam	Platelet Rich Plasma	Subjects will be randomized into the Platelet Rich Plasma group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Minoxidil Foam for 12 weeks.
Minoxidil Foam first, then Platelet Rich Plasma	Minoxidil Foam	Subjects will be randomized into the Minoxidil Foam group, treated for 12 weeks with a 2 month washout period in between treatments, then treated with Platelet Rich Plasma.

Primary Outcome Measures

Name	Time	Method
Change in Vellus Hair Density	baseline, after 12 weeks of treatment	Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of vellus hairs per cm2 was measured after both interventions, in each Arm/Group.
Change in Terminal Hair Density	baseline, after 12 weeks of treatment	Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of Terminal hairs per cm2 was measured after both interventions, in each Arm/Group.
Change in Hair Count	baseline, after 12 weeks of treatment	Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per 0.65 cm2 was measured after both interventions, in each Arm/Group.
Change in Cumulative Thickness	baseline, after 12 weeks of treatment	Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total sum of thickness of each hair was measured after both interventions, in each Arm/Group.

Secondary Outcome Measures

Name	Time	Method
Adverse Event of Swelling on Scalp	after 12 weeks of treatment	Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.
Adverse Event of Redness on Scalp	after 12 weeks of treatment	Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.