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

Primary Purpose

Alopecia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Platelet Rich Plasma

Minoxidil Foam

About this trial

This is an interventional treatment trial for Alopecia focused on measuring growth factors, hair loss, females, regenerative therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Platelet Rich Plasma first, then Minoxidil Foam

Minoxidil Foam first, then Platelet Rich Plasma

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

Secondary Outcome Measures

Adverse Event of Swelling on Scalp

Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.

Adverse Event of Redness on Scalp

Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.

Full Information

NCT ID

NCT03488108

First Posted

March 28, 2018

Last Updated

April 6, 2020

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03488108

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 23, 2017 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia

Keywords

growth factors, hair loss, females, regenerative therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet Rich Plasma first, then Minoxidil Foam

Arm Type

Experimental

Arm Description

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.

Arm Title

Minoxidil Foam first, then Platelet Rich Plasma

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Platelet Rich Plasma

Intervention Description

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

Drug

Intervention Name(s)

Minoxidil Foam

Other Intervention Name(s)

Rogaine

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hair Count

Description

Time Frame

baseline, after 12 weeks of treatment

Title

Change in Vellus Hair Density

Description

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.

Time Frame

baseline, after 12 weeks of treatment

Title

Change in Terminal Hair Density

Description

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.

Time Frame

baseline, after 12 weeks of treatment

Title

Change in Cumulative Thickness

Description

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.

Time Frame

baseline, after 12 weeks of treatment

Secondary Outcome Measure Information:

Title

Adverse Event of Swelling on Scalp

Description

Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.

Time Frame

after 12 weeks of treatment

Title

Adverse Event of Redness on Scalp

Description

Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.

Time Frame

after 12 weeks of treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Bruce, M.B. Ch.B

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31574029

Citation

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.

Results Reference

derived

Links:

URL

https://www.mayo.edu/research/clinical-trials.

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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