Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

January 23, 2017 updated by: Maja Kovacevic, MD

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil.

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events.

Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Study Type

Interventional

Phase

  • Not Applicable

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

  • Italy
    • Tuscany
      • Florence, Tuscany, Italy
        • Istituto Scienze Dermatologiche

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 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females in overall good health
  • Age: 18 to 55
  • Female pattern hair loss (Sinclair 2-4)
  • 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
  • Non-responder to 5% minoxidil as determined by the MX-IVD test i.e., low minoxidil metabolizer
  • 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
  • Use of any hypertensive drugs
  • 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 30 days
  • Responder to 5% minoxidil as determined by the MX-IVD test

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 5% Topical Minoxidil Solution
Drug: 5% Topical Minoxidil Solution
5% Topical Minoxidil Solution
Active Comparator: 15% Topical Minoxidil Solution
Drug: 15% Topical Minoxidil Solution
15% Topical Minoxidil Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Area Hair Count
Time Frame: baseline to week 24
Target Area Hair Count. Number of hairs measured in the target area by macrophotography
baseline to week 24
Subjects Ratings
Time Frame: baseline to week 24
Subjects Ratings
baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Area Hair Count
Time Frame: baseline to week 12
Target Area Hair Count. Number of hairs measured in the target area by macrophotography.
baseline to week 12
Expert Panel Global Photography Assessment
Time Frame: baseline to week 24
Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth
baseline to week 24

Collaborators and Investigators

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

Sponsor

Maja Kovacevic, MD

Investigators

  • Principal Investigator: Maja Kovacevic, MD, University of Rome, Italy ("G. Marconi")

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

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FI-DRUG-MINOXIDIL-001

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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