<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02206802</url>
  </required_header>
  <id_info>
    <org_study_id>AB-IVD-MINOXIDIL-004</org_study_id>
    <nct_id>NCT02206802</nct_id>
  </id_info>
  <brief_title>Minoxidil Response Testing in Females With Female Pattern Hair Loss</brief_title>
  <official_title>Minoxidil Response Testing in Females With Female Pattern Hair Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Applied Biology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Applied Biology, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to evaluate the clinical validity of the minoxidil&#xD;
      response in-vitro diagnostic kit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females.&#xD;
      While topical minoxidil exhibits a good safety profile, the efficacy in the overall&#xD;
      population remains relatively low i.e., 30-40% re-grow hair. To observe significant&#xD;
      improvement in hair growth, minoxidil is typically used once daily for a period of at least&#xD;
      24 weeks. Due to the significant time commitment and low response rate, a diagnostic test to&#xD;
      identify non-responders prior to initiating therapy would be advantageous.&#xD;
&#xD;
      Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the&#xD;
      sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have&#xD;
      demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked&#xD;
      hair follicles correlates with minoxidil response in the treatment of AGA and thus can server&#xD;
      as a predictive biomarker.&#xD;
&#xD;
      Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify&#xD;
      non-responders prior to initiating therapy with 5% topical minoxidil foam.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count</measure>
    <time_frame>baseline to week 24</time_frame>
    <description>Number of hairs measured in the target area by macrophotography.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings</measure>
    <time_frame>baseline to week 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count</measure>
    <time_frame>baseline to week 12</time_frame>
    <description>Number of hairs measured in the target area by macrophotography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>baseline to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>baseline to week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit</measure>
    <time_frame>baseline to week 24</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Alopecia</condition>
  <condition>Female Pattern Hair Loss</condition>
  <arm_group>
    <arm_group_label>Predicted as non-responders</arm_group_label>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Predicted as responders</arm_group_label>
    <description>Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5% minoxidil topical foam</intervention_name>
    <description>5% minoxidil topical foam</description>
    <arm_group_label>Predicted as non-responders</arm_group_label>
    <arm_group_label>Predicted as responders</arm_group_label>
    <other_name>Rogaine 5% minoxidil foam</other_name>
    <other_name>Regaine 5% minoxidil foam</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plucked hair follicles with visible bulbs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Females with Female Pattern Hair Loss - Androgenetic Alopecia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females in overall good health&#xD;
&#xD;
          -  Age: 18 or older&#xD;
&#xD;
          -  Female pattern hair loss&#xD;
&#xD;
          -  Willing to have a mini dot tattoo placed in the target area of the scalp&#xD;
&#xD;
          -  Willing to maintain the same hair style, color, shampoo and hair products use, and&#xD;
             approximate hair length throughout the study&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Able to comply with the study requirements for 24 consecutive weeks&#xD;
&#xD;
          -  Willing to use an adequate method of birth control (if applicable)&#xD;
&#xD;
          -  Negative urine pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous adverse event from topical minoxidil treatment&#xD;
&#xD;
          -  History of hypotension&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Pregnant, nursing, or planning a pregnancy during the study&#xD;
&#xD;
          -  Prior hair transplant&#xD;
&#xD;
          -  Uses wigs or hair weaves&#xD;
&#xD;
          -  Have used minoxidil (topical or oral) anytime during the past 6 months&#xD;
&#xD;
          -  Chronic scalp disorders that require medications&#xD;
&#xD;
          -  Uses medication known to cause hair thinning such as Coumadin and&#xD;
             anti-depressants/anti-psychotics&#xD;
&#xD;
          -  Folliculitis&#xD;
&#xD;
          -  Scalp psoriasis&#xD;
&#xD;
          -  Seborrheic dermatitis&#xD;
&#xD;
          -  Inflammatory scalp conditions such as lichen planopilaris&#xD;
&#xD;
          -  Enrolled in any other medical study or has been enrolled in any medical study in the&#xD;
             past 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Keene, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Hair Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Flavio Grasso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Medico Tricologico/Studi Life Cronos</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rodney Sinclair, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sinclair Dermatology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachita Dhurat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LTM Medical College &amp; Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Hair Institute</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinclair Dermatology</name>
      <address>
        <city>East Melbourne</city>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTM Medical College &amp; Hospital</name>
      <address>
        <city>Mumbai</city>
        <zip>400022</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Medico Tricologico/Studi Life Cronos</name>
      <address>
        <city>Florence</city>
        <zip>50127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>India</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28.</citation>
    <PMID>24773771</PMID>
  </reference>
  <reference>
    <citation>Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27.</citation>
    <PMID>24283387</PMID>
  </reference>
  <reference>
    <citation>Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905.</citation>
    <PMID>2230218</PMID>
  </reference>
  <reference>
    <citation>Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.</citation>
    <PMID>14996087</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alopecia</keyword>
  <keyword>Androgenetic Alopecia</keyword>
  <keyword>Female Pattern Hair Loss</keyword>
  <keyword>Hair Loss</keyword>
  <keyword>Minoxidil</keyword>
  <keyword>Hair Thinning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Minoxidil</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02206802
org study id: AB-IVD-MINOXIDIL-004
nct id: NCT02206802
lead sponsor: 
has dmc: No
The primary purpose of this study is to evaluate the clinical validity of the minoxidil
      response in-vitro diagnostic kit.
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.
observational model: Case-Control
time perspective: Prospective
measure: 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
description: Number of hairs measured in the target area by macrophotography.
measure: Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
time frame: baseline to week 24
measure: 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
description: Number of hairs measured in the target area by macrophotography.
measure: 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
measure: 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
measure: 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
arm group label: 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.
arm group label: Predicted as responders
description: Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.
intervention type: Drug
intervention name: 5% minoxidil topical foam
description: 5% minoxidil topical foam
arm group label: Predicted as non-responders
arm group label: Predicted as responders
other name: Rogaine 5% minoxidil foam
other name: Regaine 5% minoxidil foam
Plucked hair follicles with visible bulbs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sharon Keene, MD
role: Principal Investigator
affiliation: Physicians Hair Institute
last name: Flavio Grasso, MD
role: Principal Investigator
affiliation: Istituto Medico Tricologico/Studi Life Cronos
last name: Rodney Sinclair, MD
role: Principal Investigator
affiliation: Sinclair Dermatology
last name: Rachita Dhurat, MD
role: Principal Investigator
affiliation: LTM Medical College & Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: India
country: Italy
country: United States
citation: Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28.
PMID: 24773771
citation: Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27.
PMID: 24283387
citation: Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905.
PMID: 2230218
citation: Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x.
PMID: 14996087
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Minoxidil