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

NCT03488108 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 16-003335
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia

Keywords

growth factors, hair loss, females, regenerative therapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Adverse Event of Swelling on Scalp

  after 12 weeks of treatment

• Adverse Event of Redness on Scalp

  after 12 weeks of treatment

Study Arms (2)

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.

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.

Other: Platelet Rich Plasma; Drug: Minoxidil Foam

Interventions

Platelet Rich Plasma 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 first, then Platelet Rich Plasma; Platelet Rich Plasma first, then Minoxidil Foam

Minoxidil Foam DRUG

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

Also known as: Rogaine

Minoxidil Foam first, then Platelet Rich Plasma; Platelet Rich Plasma first, then Minoxidil Foam

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• 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.

  PMID: 31574029 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Alison J. Bruce, M.B., Ch.B
• Organization: Mayo Clinic

Bruce.Alison@mayo.edu

904-953-6412

Study Officials

• Alison Bruce, M.B. Ch.B

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 4, 2018
• Study Start: January 23, 2017
• Primary Completion: May 31, 2018
• Study Completion: June 17, 2019
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)