<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/NCT01672307</url>
  </required_header>
  <id_info>
    <org_study_id>MFL University</org_study_id>
    <nct_id>NCT01672307</nct_id>
  </id_info>
  <brief_title>Minoxidil 2% for Eyebrow Enhancement</brief_title>
  <official_title>Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mae Fah Luang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mae Fah Luang University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of&#xD;
      eyebrows.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of global photographic assessment after 16 weeks from baseline</measure>
    <time_frame>baseline and 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of hair diameter after 16 weeks from baseline</measure>
    <time_frame>baseline and 16 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>The change in number of hairs after 16 weeks from baseline</measure>
    <time_frame>baseline and 16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events. Adverse events include any skin rashes or symptoms.</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Patient satisfaction by self-assessment questionnaires</measure>
    <time_frame>16 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypotrichosis of Eyebrows</condition>
  <condition>Thinning Eyebrows</condition>
  <arm_group>
    <arm_group_label>Minoxidil lotion 2%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minoxidil lotion 2% is applied twice daily to one eyebrow.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is applied twice daily to the other eyebrow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Minoxidil lotion 2%</intervention_name>
    <description>Minoxidil lotion 2% is applied twice daily to one eyebrow.</description>
    <arm_group_label>Minoxidil lotion 2%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is applied twice daily to the other eyebrow.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male or female aged 18-40 years&#xD;
&#xD;
          -  hypotrichosis of eyebrows&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no underlying diseases&#xD;
&#xD;
          -  no alopecia areata or trichotillomania&#xD;
&#xD;
          -  no thyroid diseases&#xD;
&#xD;
          -  no pregnancy or breast feeding&#xD;
&#xD;
          -  no previous eyebrow tattoo, trauma or accident.&#xD;
&#xD;
          -  no history of eyebrow or hair medications in 6 months&#xD;
&#xD;
          -  no history of minoxidil or its ingredient allergy&#xD;
&#xD;
          -  no history of eyebrow surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuchai Tanglertsampan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MFL University Hospital (Bangkok)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MFL University Hospital (Bangkok)</name>
      <address>
        <city>Bangkok</city>
        <zip>10110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>June 18, 2013</last_update_submitted>
  <last_update_submitted_qc>June 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mae Fah Luang University Hospital</investigator_affiliation>
    <investigator_full_name>Chuchai TANGLERTSAMPAN, MD</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>hypotrichosis of eyebrows</keyword>
  <keyword>thinning eyebrows</keyword>
  <keyword>minoxidil</keyword>
  <keyword>placebo</keyword>
  <keyword>randomized</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotrichosis</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/NCT01672307
org study id: MFL University
nct id: NCT01672307
lead sponsor: 
has dmc: No
The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of
      eyebrows.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change of global photographic assessment after 16 weeks from baseline
time frame: baseline and 16 weeks
measure: The change of hair diameter after 16 weeks from baseline
time frame: baseline and 16 weeks
measure: The change in number of hairs after 16 weeks from baseline
time frame: baseline and 16 weeks
measure: Number of participants with adverse events. Adverse events include any skin rashes or symptoms.
time frame: 16 weeks
measure: Patient satisfaction by self-assessment questionnaires
time frame: 16 weeks
arm group label: Minoxidil lotion 2%
arm group type: Experimental
description: Minoxidil lotion 2% is applied twice daily to one eyebrow.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is applied twice daily to the other eyebrow.
intervention type: Drug
intervention name: Minoxidil lotion 2%
description: Minoxidil lotion 2% is applied twice daily to one eyebrow.
arm group label: Minoxidil lotion 2%
intervention type: Drug
intervention name: Placebo
description: Placebo is applied twice daily to the other eyebrow.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chuchai Tanglertsampan, MD
role: Principal Investigator
affiliation: MFL University Hospital (Bangkok)
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Mae Fah Luang University Hospital
investigator full name: Chuchai TANGLERTSAMPAN, MD
investigator title: Instructor
mesh term: Hypotrichosis
mesh term: Minoxidil