Minoxidil Response Testing in Males With Androgenetic Alopecia

October 4, 2018 updated by: Applied Biology, Inc.

Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.

Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.

Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • East Melbourne, Australia, 3002
        • Sinclair Dermatology
      • Mumbai, India, 400022
        • LTM Medical College & Hospital
      • Florence, Italy, 50127
        • Istituto Medico Tricologico/Studi Life Cronos
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Physicians Hair Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Males with androgenetic alopecia

Description

Inclusion Criteria:

  • Males in overall good health
  • Age: 18 to 49
  • Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
  • Willing to have a mini dot tattoo placed in the target area of the scalp
  • Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
  • Able to give informed consent
  • Able to comply with the study requirements for 16 consecutive weeks

Exclusion Criteria:

  • Previous adverse event from topical minoxidil treatment
  • Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride
  • Does not use and have not used in the past 6 months minoxidil (topical or oral)
  • Does not take medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
  • Folliculitis
  • Scalp psoriasis
  • Seborrheic dermatitis
  • Inflammatory scalp conditions such as lichen planopilaris

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Predicted as non-responders
Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam
Predicted as responders
Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region
Time Frame: baseline to week 16
baseline to week 16
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Time Frame: baseline to week 16
baseline to week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth
Time Frame: baseline to week 16
baseline to week 16
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region
Time Frame: baseline to week 16
baseline to week 16
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
Time Frame: baseline to week 16
baseline to week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sharon Keene, MD, Physicians Hair Institute
  • Principal Investigator: Flavio Grasso, MD, Istituto Medico Tricologico/Studi Life Cronos
  • Principal Investigator: Rodney Sinclair, MD, Sinclair Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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