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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Target Area Hair Count

Secondary Outcome

 Target Area Hair Count

Condition

Female Pattern Hair Loss

Intervention

5% Topical Minoxidil Solution

Study Arms / Comparison Groups

 5% Topical Minoxidil Solution
Description:  5% Topical Minoxidil Solution

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

0

Start Date

June 2016

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Maja Kovacevic, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02486848

Organization ID

FI-DRUG-MINOXIDIL-001


Responsible Party

Sponsor-Investigator

Study Sponsor

Maja Kovacevic, MD


Study Sponsor

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


Verification Date

January 2017