Minoxidil Response Testing in Females With Female Pattern Hair Loss

October 4, 2018 updated by: Applied Biology, Inc.
The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females. 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 once daily for a period of at least 24 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.

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

  • Australia
      • East Melbourne, Australia, 3002
        • Sinclair Dermatology
  • India
      • Mumbai, India, 400022
        • LTM Medical College & Hospital
  • Italy
      • Florence, Italy, 50127
        • Istituto Medico Tricologico/Studi Life Cronos
  • United States
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females with Female Pattern Hair Loss - Androgenetic Alopecia

Description

Inclusion Criteria:

  • Females in overall good health
  • Age: 18 or older
  • Female pattern hair loss
  • 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 24 consecutive weeks
  • Willing to use an adequate method of birth control (if applicable)
  • Negative urine pregnancy test

Exclusion Criteria:

  • Previous adverse event from topical minoxidil treatment
  • History of hypotension
  • Uncontrolled hypertension
  • Pregnant, nursing, or planning a pregnancy during the study
  • Prior hair transplant
  • Uses wigs or hair weaves
  • Have used minoxidil (topical or oral) anytime during the past 6 months
  • Chronic scalp disorders that require medications
  • Uses 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
  • Enrolled in any other medical study or has been enrolled in any medical study in the past 6 months

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.
Drug: 5% minoxidil topical foam
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.
Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
Time Frame: baseline to week 24
Number of hairs measured in the target area by macrophotography.
baseline to week 24
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Time Frame: baseline to week 24
baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
Time Frame: baseline to week 12
Number of hairs measured in the target area by macrophotography.
baseline to week 12
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 24
baseline to week 24
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 24
baseline to week 24
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
Time Frame: baseline to week 24
baseline to week 24

Collaborators and Investigators

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

Sponsor

Applied Biology, Inc.

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
  • Principal Investigator: Rachita Dhurat, MD, LTM Medical College & Hospital

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.

General Publications

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 31, 2014

First Submitted That Met QC Criteria

July 31, 2014

First Posted (Estimate)

August 1, 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

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-IVD-MINOXIDIL-004

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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