MedTrace Logo

Minoxidil Response Testing in Males With Androgenetic Alopecia

NCT02198261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-10-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

5% minoxidil topical foam

5% minoxidil topical foam

Sponsors & Collaborators

  • Applied Biology, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Keene, MD · Physicians Hair Institute

  • Flavio Grasso, MD · Istituto Medico Tricologico/Studi Life Cronos

  • Rodney Sinclair, MD · Sinclair Dermatology

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • United States
  • Australia
  • India
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02198261 on ClinicalTrials.gov