Minoxidil Response Testing in Males With Androgenetic Alopecia

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Brief Title

Minoxidil Response Testing in Males With Androgenetic Alopecia

Official Title

Minoxidil Response Testing in Males With Androgenetic Alopecia

Brief 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.
    



Study Type

Observational


Primary Outcome

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

Secondary Outcome

 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

Condition

Androgenetic Alopecia

Intervention

5% minoxidil topical foam

Study Arms / Comparison Groups

 Predicted as non-responders
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

July 2014

Completion Date

October 2018

Primary Completion Date

October 2018

Eligibility Criteria

        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
      

Gender

Male

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

No

Contacts

Sharon Keene, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT02198261

Organization ID

AB-IVD-MINOXIDIL-003


Responsible Party

Sponsor

Study Sponsor

Applied Biology, Inc.


Study Sponsor

Sharon Keene, MD, Principal Investigator, Physicians Hair Institute


Verification Date

October 2018