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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alopecia

Intervention / Treatment
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* Other: Platelet Rich Plasma
* Drug: Minoxidil Foam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma first, then Minoxidil Foam<br>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. | Other: Platelet Rich Plasma<br>* 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.<br>Drug: Minoxidil Foam<br>* Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.<br>* Other names: Rogaine;|
| Experimental: Minoxidil Foam first, then Platelet Rich Plasma<br>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. | Other: Platelet Rich Plasma<br>* 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.<br>Drug: Minoxidil Foam<br>* Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.<br>* Other names: Rogaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hair Count | 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. | baseline, after 12 weeks of treatment | 
| Change in Vellus Hair Density | 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. | baseline, after 12 weeks of treatment | 
| Change in Terminal Hair Density | 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. | baseline, after 12 weeks of treatment | 
| Change in Cumulative Thickness | 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. | baseline, after 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event of Swelling on Scalp | Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group. | after 12 weeks of treatment | 
| Adverse Event of Redness on Scalp | Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group. | after 12 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth factors, hair loss, females, regenerative therapy