Skip to main content
OpenTrials
Completed

NCT Number: NCT03488108

Platelet Rich Plasma Versus 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Rogaine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Adverse Event of Swelling on Scalp

    Time frame: 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

    Time frame: after 12 weeks of treatment

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.