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

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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Other: Platelet Rich Plasma; Drug: Minoxidil Foam

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Drug: Minoxidil Foam; Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.; Other Names: Rogaine
Experimental: 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.	Other: 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.; Drug: Minoxidil Foam; Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.; Other Names: Rogaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Alison Bruce, M.B. Ch.B, Mayo Clinic

Publications and helpful links

General Publications

• Bruce AJ, Pincelli TP, Heckman MG, Desmond CM, Arthurs JR, Diehl NN, Douglass EJ, Bruce CJ, Shapiro SA. A Randomized, Controlled Pilot Trial Comparing Platelet-Rich Plasma to Topical Minoxidil Foam for Treatment of Androgenic Alopecia in Women. Dermatol Surg. 2020 Jun;46(6):826-832. doi: 10.1097/DSS.0000000000002168.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): June 17, 2019

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: growth factors, hair loss, females, regenerative therapy
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: 16-003335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No