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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2019-06-17

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.

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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.

Conditions

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Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Platelet Rich Plasma first, then 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.

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type OTHER

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.

Minoxidil Foam

Intervention Type DRUG

Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.

Minoxidil Foam first, then 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.

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type OTHER

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.

Minoxidil Foam

Intervention Type DRUG

Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.

Interventions

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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.

Intervention Type OTHER

Minoxidil Foam

Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Rogaine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes