AlopeciaPhase 1/2NCT03488108

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

A Phase 1/2 study testing Platelet Rich Plasma and Minoxidil Foam in people with Alopecia, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Alopecia
What is being tested?: Platelet Rich Plasma and Minoxidil Foam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2017to 17 Jun 2019
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Alopecia
Being tested: Platelet Rich Plasma, Minoxidil Foam
Keywords: growth factors, hair loss, females, regenerative therapy
Medical subject headings: Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Platelet Rich PlasmaOther
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 FoamDrug
Also called Rogaine
Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.

Study groups in NCT03488108
Study group	Role	What they receive
Platelet Rich Plasma first, then Minoxidil Foam	Experimental	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. Receives: Other: Platelet Rich Plasma; Drug: Minoxidil Foam
Minoxidil Foam first, then Platelet Rich Plasma	Experimental	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. Receives: Other: Platelet Rich Plasma; Drug: Minoxidil Foam

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, after 12 weeks of treatment

Secondary outcomes (2)

Adverse Event of Swelling on Scalp
Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.
Measured: 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.
Measured: after 12 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 201717 Jun 2019

First posted4 Apr 2018
Study start23 Jan 2017
Primary completion31 May 2018
Study completion17 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AlopeciaStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03488108
Sponsor's protocol ID: 16-003335
Status last verified: Apr 2020
First submitted: 28 Mar 2018
Last updated: 8 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 31574029

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
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Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
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Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
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All Alopecia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial Comparing Platelet Rich Plasma (PRP) to Minoxidil Foam for Treatment of Androgenic Alopecia in Women
ClinicalTrials.gov ID: NCT03488108
Acronym / sponsor ID: 16-003335
Conditions: Alopecia
Keywords: growth factors, hair loss, females, regenerative therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 23 Jan 2017 (actual)
Primary completion: 31 May 2018 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 4 Apr 2018 (actual)
Results: Posted 8 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Platelet Rich Plasma first, then Minoxidil Foam	Experimental	Other: Platelet Rich Plasma, Drug: Minoxidil FoamSubjects 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.
Minoxidil Foam first, then Platelet Rich Plasma	Experimental	Other: Platelet Rich Plasma, Drug: Minoxidil FoamSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Platelet Rich PlasmaAutologous 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.	Other	Minoxidil Foam first, then Platelet Rich Plasma, Platelet Rich Plasma first, then Minoxidil Foam
Minoxidil FoamAlso: RogaineMinoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.	Drug	Minoxidil Foam first, then Platelet Rich Plasma, Platelet Rich Plasma first, then Minoxidil Foam

Primary outcome

Change in Hair Count
Time frame: 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.
Change in Vellus Hair Density
Time frame: 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.
Change in Terminal Hair Density
Time frame: 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.
Change in Cumulative Thickness
Time frame: 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.

2 secondary outcomes

Adverse Event of Swelling on Scalp
Time frame: after 12 weeks of treatment
Adverse Event of Redness on Scalp
Time frame: after 12 weeks of treatment

Results and safety

Results posted to the registry on 8 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Platelet Rich Plasma First, Then Minoxidil Foam	10	10
Minoxidil Foam First, Then Platelet Rich Plasma	10	9

Primary outcome: Change in Hair Count

Time frame: baseline, after 12 weeks of treatment. Median (Inter-Quartile Range). Unit: percent change

Measure	Platelet Rich Plasma n = 19	Minoxidil Foam n = 18
Value	7.7 (-7.2 to 17.9)	22.7 (-18.0 to 59.0)

Platelet Rich Plasma vs Minoxidil Foam: p = .009, Wilcoxon (Mann-Whitney)

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

Primary outcome: Change in Vellus Hair Density

Time frame: baseline, after 12 weeks of treatment. Median (Inter-Quartile Range). Unit: percent change

Measure	Platelet Rich Plasma n = 19	Minoxidil Foam n = 18
Value	25.7 (-37.6 to 121.3)	18.6 (-29.4 to 166.5)

Platelet Rich Plasma vs Minoxidil Foam: p = .90, Wilcoxon (Mann-Whitney)

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

Primary outcome: Change in Terminal Hair Density

Time frame: baseline, after 12 weeks of treatment. Median (Inter-Quartile Range). Unit: percent change

Measure	Platelet Rich Plasma n = 19	Minoxidil Foam n = 18
Value	-0.7 (-49.5 to 27.6)	12.8 (-19.4 to 119.4)

Platelet Rich Plasma vs Minoxidil Foam: p = .003, Wilcoxon (Mann-Whitney)

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

Primary outcome: Change in Cumulative Thickness

Time frame: baseline, after 12 weeks of treatment. Median (Inter-Quartile Range). Unit: percent change

Measure	Platelet Rich Plasma n = 19	Minoxidil Foam n = 18
Value	-3.5 (-14.1 to 32.2)	20.6 (-21.3 to 83.3)

Platelet Rich Plasma vs Minoxidil Foam: p = .005, Wilcoxon (Mann-Whitney)

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

2 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Platelet Rich Plasma	0 of 19 (0%)	3 of 19 (15.8%)	0 of 19
Minoxidil Foam	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31574029Bruce 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.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Alopecia

Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Bruce, M.B. Ch.B principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Platelet Rich Plasma and Minoxidil Foam in people with Alopecia, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hair Count (time frame: baseline, after 12 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03488108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.