<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/NCT01662089</url>
  </required_header>
  <id_info>
    <org_study_id>SirirajH-004</org_study_id>
    <nct_id>NCT01662089</nct_id>
  </id_info>
  <brief_title>The Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Zinc Supplement</brief_title>
  <official_title>A Pilot Study of the Efficacy in Treatment of Female Pattern Hair Loss Using 5% Minoxidil Solution Combinded With Oral Chelated Zinc Supplement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Siriraj Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Siriraj Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient.&#xD;
      But the type of patient, efficacy, and side effect in detail of zinc supplement are not well&#xD;
      characterized. The purpose of this study is to determine efficacy and side effect of chelated&#xD;
      zinc in FPHL who using 5%minoxidil solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We&#xD;
      gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure&#xD;
      growth of hair by Global photograph, Microscope hair count, micrometer and record case and&#xD;
      side effect during 10 months of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare clinical improvement before and after treatment</measure>
    <time_frame>6 month</time_frame>
    <description>Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare hair density before and after treatmen</measure>
    <time_frame>6 month</time_frame>
    <description>Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare average hair shaft diameter before and after treatment</measure>
    <time_frame>6 month</time_frame>
    <description>Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of pateint with Side effect</measure>
    <time_frame>6 month</time_frame>
    <description>Using side effect record form to record side effect from treatment Count number of pateint with side effect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Female Pattern Alopecia</condition>
  <arm_group>
    <arm_group_label>Chelate zinc suppliment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15mg Chelate zinc suppliment : additional to standard 5% minoxidil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo drug</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>15 mg Chelate zinc supplement</intervention_name>
    <description>15 mg Chelate zinc additional to standard 5% minoxidil</description>
    <arm_group_label>Chelate zinc suppliment</arm_group_label>
    <other_name>zinc, Zn</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo drug supplement</intervention_name>
    <description>Placebo drug instead of Zinc supplement</description>
    <arm_group_label>Placebo drug</arm_group_label>
    <other_name>starch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female Pattern Hair Loss ( Ludwig classification grade 1 and 2 )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying disease ; Anemia, Diabetes, chronic alcoholism, previous gastrointestinal&#xD;
             surgery, short bowel syndrome, Crohn's disease, digestive disorder,&#xD;
             hypo/hyperthyroidism, sickle cell disease, autoimmune disease, iron deficiency&#xD;
&#xD;
          -  Psychologic disorder trichotillomania&#xD;
&#xD;
          -  Diet control&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  On supplement diet within 3 month prior to trial&#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_contact>
    <last_name>Rattapon Thuangtong, MD</last_name>
    <phone>+662 419-7000</phone>
    <phone_ext>4333</phone_ext>
    <email>rattapongthuangtong@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rattapon Thuangtong, MD</last_name>
      <phone>+662 419-7000</phone>
      <phone_ext>4333</phone_ext>
      <email>rattapongthuangtong@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Siriraj Hospital</investigator_affiliation>
    <investigator_full_name>Rattapon Thuangtong</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Female pattern hair loss</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>Zinc</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/NCT01662089
org study id: SirirajH-004
nct id: NCT01662089
lead sponsor: 
has dmc: Yes
Zinc supplement is a popular trace element gave to Female pattern hair loss (FPHL) patient.
      But the type of patient, efficacy, and side effect in detail of zinc supplement are not well
      characterized. The purpose of this study is to determine efficacy and side effect of chelated
      zinc in FPHL who using 5%minoxidil solution.
5%minoxidil solution is standard treatment for Female pattern hair loss (FPHL) patient. We
      gave 15mg chelate Zinc / Placebo drug to patient as an additional trace element. Then measure
      growth of hair by Global photograph, Microscope hair count, micrometer and record case and
      side effect during 10 months of treatment.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Compare clinical improvement before and after treatment
time frame: 6 month
description: Measure clinical by Global photographic view using 7 point scale. Review picture by 2 dermatologist
measure: Compare hair density before and after treatmen
time frame: 6 month
description: Measure Hair density by microscope photo of area 1 cm2. Conut number of hair in photo.
measure: Compare average hair shaft diameter before and after treatment
time frame: 6 month
description: Compare average hair shaft diameter before and after treatment Measure hair shaft diameter using electronic outside micrometer.
measure: Number of pateint with Side effect
time frame: 6 month
description: Using side effect record form to record side effect from treatment Count number of pateint with side effect.
arm group label: Chelate zinc suppliment
arm group type: Experimental
description: 15mg Chelate zinc suppliment : additional to standard 5% minoxidil
arm group label: Placebo drug
arm group type: Placebo Comparator
description: Placebo drug to compare with 15mg chelated Zn : additional to standard 5% minoxidil
intervention type: Drug
intervention name: 15 mg Chelate zinc supplement
description: 15 mg Chelate zinc additional to standard 5% minoxidil
arm group label: Chelate zinc suppliment
other name: zinc, Zn
intervention type: Drug
intervention name: Placebo drug supplement
description: Placebo drug instead of Zinc supplement
arm group label: Placebo drug
other name: starch
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rattapon Thuangtong, MD
phone: +662 419-7000
phone ext: 4333
email: rattapongthuangtong@yahoo.com
facility: 
status: Recruiting
contact: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Siriraj Hospital
investigator full name: Rattapon Thuangtong
investigator title: Associate Professor
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Zinc