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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03488108
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.7
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia	Other: Platelet Rich Plasma; Drug: Minoxidil Foam	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial Comparing Platelet Rich Plasma (PRP) to Minoxidil Foam for Treatment of Androgenic Alopecia in Women
• Actual Study Start Date: Jan 23, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: Jun 17, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2016

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Alison J. Bruce, Associate Professor of Dermatology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03488108
• Other Study ID Numbers: 16-003335
• First Posted: Apr 4, 2018
• Last Update Posted: Apr 8, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alison J. Bruce, Associate Professor of Dermatology, Mayo Clinic: growth factors, hair loss, females, regenerative therapy
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Minoxidil

Study Results

Participant Flow

Arm/Group Title	Platelet Rich Plasma First, Then Minoxidil Foam	Minoxidil Foam First, Then Platelet Rich Plasma
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study 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. 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. Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.	Subjects who received Minoxidil either the first or last 12 weeks of the study 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: 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: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
Period Title: First Intervention (12 Weeks)
STARTED	10	10
COMPLETED	10	9
NOT COMPLETED	0	1
Period Title: First Intervention (12 Weeks)
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0
Period Title: First Intervention (12 Weeks)
STARTED	10	9
COMPLETED	9	9
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Platelet Rich Plasma First, Then Minoxidil Foam	Minoxidil Foam First, Then Platelet Rich Plasma	Total
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study 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. 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. Minoxidil Foam: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.	Subjects who received Minoxidil either the first or last 12 weeks of the study 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: 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: Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.	Total of all reporting groups
Overall Participants	10	9	19
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51	56	56
Sex: Female, Male (Count of Participants)
Female	10 100%	9 100%	19 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	10 100%	9 100%	19 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	9 100%	19 100%

Outcome Measures

1. Primary Outcome

Title	Change in Hair Count
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 hairs per 0.65 cm2 was measured after both interventions, in each Arm/Group.
Time Frame	baseline, after 12 weeks of treatment

Outcome Measure Data

Analysis Population Description

One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study.	Subjects who received Minoxidil either the first or last 12 weeks of the study.
Measure Participants	19	18
Median (Inter-Quartile Range) [percent change]	7.7	22.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Platelet Rich Plasma, Minoxidil Foam
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.009
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study	Subjects who received Minoxidil either the first or last 12 weeks of the study
Measure Participants	19	18
Median (Inter-Quartile Range) [percent change]	25.7	18.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Platelet Rich Plasma, Minoxidil Foam
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.90
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study	Subjects who received Minoxidil either the first or last 12 weeks of the study
Measure Participants	19	18
Median (Inter-Quartile Range) [percent change]	-0.7	12.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Platelet Rich Plasma, Minoxidil Foam
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.003
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study	Subjects who received Minoxidil either the first or last 12 weeks of the study
Measure Participants	19	18
Median (Inter-Quartile Range) [percent change]	-3.5	20.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Platelet Rich Plasma, Minoxidil Foam
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study	Subjects who received Minoxidil either the first or last 12 weeks of the study
Measure Participants	19	19
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet Rich Plasma	Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study	Subjects who received Minoxidil either the first or last 12 weeks of the study
Measure Participants	19	19
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Adverse events were assessed during first treatment period, washout period, second treatment period and follow up period for a total of approximately 1 year.
Arm/Group Title	Platelet Rich Plasma		Minoxidil Foam
Arm/Group Description	Subjects who received PRP in either the first or last 12 weeks of the study 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.		Subjects who received Minoxidil either the first or last 12 weeks of the study Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
All Cause Mortality
	Platelet Rich Plasma		Minoxidil Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)
Serious Adverse Events
	Platelet Rich Plasma		Minoxidil Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Platelet Rich Plasma		Minoxidil Foam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)		1/18 (5.6%)
General disorders
Pain	2/19 (10.5%)	2	0/18 (0%)	0
Skin and subcutaneous tissue disorders
Itching	1/19 (5.3%)	1	0/18 (0%)	0
Bruising	0/19 (0%)	0	1/18 (5.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.