<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/NCT03753113</url>
  </required_header>
  <id_info>
    <org_study_id>TabrizUMS</org_study_id>
    <nct_id>NCT03753113</nct_id>
  </id_info>
  <brief_title>Evaluating the Topical Herbal Solution on the Treatment of Male Pattern Hair Loss and Comparison With Minoxidil 5%</brief_title>
  <official_title>Evaluating the Efficacy of Topical Herbal Solution on the Treatment of Androgenetic Alopecia and Comparison With Minoxidil 5%: A Double-Blind, Randomized, Clinical Trial Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Farid Masoud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tabriz University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is evaluating the efficacy and safety of a topical herbal solution&#xD;
      in males for the treatment of Androgenetic alopecia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will&#xD;
      be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible&#xD;
      individuals will be selected among them. Subjects were randomized to use either Topical&#xD;
      Herbal Solution or Topical Minoxidil 5% for 36 weeks.&#xD;
&#xD;
      To our knowledge, this herbal solution for the first time covers all four major causes of&#xD;
      AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting&#xD;
      dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple&#xD;
      mechanism. The application of this new herbal solution for the treatment of AGA should be&#xD;
      recommended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">September 2, 2019</completion_date>
  <primary_completion_date type="Actual">September 2, 2019</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hair Diameter</measure>
    <time_frame>baseline, 12, 24, and 36 weeks</time_frame>
    <description>Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients Self - Assessment Questionnaire</measure>
    <time_frame>through study completion</time_frame>
    <description>Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>baseline, 12, 24, and 36 weeks</time_frame>
    <description>Incidence of adverse events such as itching, redness, inflammation etc</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Androgenetic Alopecia</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Herbal Solution</intervention_name>
    <description>Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical Minoxidil 5%</intervention_name>
    <description>Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>Minoxidil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men 18 to 50 years old&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Normal general health status&#xD;
&#xD;
          -  Men who have a presentation of androgenetic alopecia (Norwood II - V).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any topical product in the target region interfering with the study product in&#xD;
             the last three months&#xD;
&#xD;
          -  Within the past 6 months receiving of chemotherapy/cytotoxic agents&#xD;
&#xD;
          -  Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Any dermatological disorders in the scalp, such as fungal or bacterial infections,&#xD;
             eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer&#xD;
&#xD;
          -  Hormonal diseases such as thyroid disorders, diabetes and, ...&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Liver and kidney disease&#xD;
&#xD;
          -  History of hair transplants&#xD;
&#xD;
          -  History of surgical correction of hair loss on the scalp&#xD;
&#xD;
          -  Subject having dyed, bleached hair or, with a permanent wave prior to study start.&#xD;
&#xD;
          -  No written consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Healthy men 18 to 50 years old</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farid Masoud, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pharmacy Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yousef Javadzadeh, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Department of Pharmaceutics, Pharmacy Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hamideh Azimi Alamdari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Solmaz Asnaashari, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Department of Pharmacognosy, Pharmacy Faculty</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Javad Shokri, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Department of Pharmaceutics, Pharmacy Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Sina Hospital</name>
      <address>
        <city>Tabriz</city>
        <state>East Azerbaijan</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <results_first_submitted>January 18, 2020</results_first_submitted>
  <results_first_submitted_qc>March 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2020</results_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tabriz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Farid Masoud</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Androgenic Alopecia</keyword>
  <keyword>Hair Diseases</keyword>
  <keyword>Skin Diseases</keyword>
  <keyword>Baldness</keyword>
  <keyword>Alopecia</keyword>
  <keyword>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>Minoxidil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03753113/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>At the Week 0 administration, subject demographics, hair diameter, and duration of androgenetic alopecia acquired.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.45" spread="5.744"/>
                    <measurement group_id="B2" value="33.67" spread="6.065"/>
                    <measurement group_id="B3" value="33.04" spread="5.812"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Iran</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hair diameter</title>
          <units>micrometer</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.75" spread="8.74"/>
                    <measurement group_id="B2" value="54" spread="6.729"/>
                    <measurement group_id="B3" value="53.38" spread="7.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of androgenetic alopecia</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.58" spread="2.24"/>
                    <measurement group_id="B2" value="4.42" spread="2.47"/>
                    <measurement group_id="B3" value="4.5" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of androgenetic alopecia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of the disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hypo/Hyperthyroidism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Hair Diameter</title>
        <description>Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.</description>
        <time_frame>baseline, 12, 24, and 36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hair Diameter</title>
          <description>Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.</description>
          <units>micrometer</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.42" spread="8.88"/>
                    <measurement group_id="O2" value="51.58" spread="7.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.92" spread="7.35"/>
                    <measurement group_id="O2" value="51.17" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.67" spread="7.19"/>
                    <measurement group_id="O2" value="50.58" spread="7.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients Self - Assessment Questionnaire</title>
        <description>Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.</description>
        <time_frame>through study completion</time_frame>
        <population>All participants for whom data were collected at weeks 36.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Self - Assessment Questionnaire</title>
          <description>Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.</description>
          <population>All participants for whom data were collected at weeks 36.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="0.452"/>
                    <measurement group_id="O2" value="2.58" spread="0.669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Incidence of adverse events such as itching, redness, inflammation etc</description>
        <time_frame>baseline, 12, 24, and 36 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Incidence of adverse events such as itching, redness, inflammation etc</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>scalp itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>scalp dryness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the beginning of the study until 9 months</time_frame>
      <desc>According to its herbal origin and topical administration, In both groups, neither all-cause mortality nor serious adverse events were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>The patients applied 1 mL of solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Herbal Solution: Use Topical Herbal Solution every day in scalp hair loss areas for 9 months&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks&#xD;
Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>scalp itching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>scalp dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small numbers of subjects</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Farid Masoud</name_or_title>
      <organization>Tabriz University of Medical Sciences</organization>
      <phone>+989036859062</phone>
      <email>faridmasoud@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03753113
org study id: TabrizUMS
nct id: NCT03753113
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is evaluating the efficacy and safety of a topical herbal solution
      in males for the treatment of Androgenetic alopecia.
This study will be done on male subjects with Androgenetic alopecia(AGA). The patients will
      be selected by volunteers attending the Dermatology department of Sina Hospital, and eligible
      individuals will be selected among them. Subjects were randomized to use either Topical
      Herbal Solution or Topical Minoxidil 5% for 36 weeks.

      To our knowledge, this herbal solution for the first time covers all four major causes of
      AGA, including the 5α-reductase enzyme, androgen receptors, paracrine agents that affecting
      dermal papilla and hair cell apoptosis processes. Therefore it acts with the quadruple
      mechanism. The application of this new herbal solution for the treatment of AGA should be
      recommended.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Hair Diameter
time frame: baseline, 12, 24, and 36 weeks
description: Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.
measure: Patients Self - Assessment Questionnaire
time frame: through study completion
description: Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.
measure: Adverse Events
time frame: baseline, 12, 24, and 36 weeks
description: Incidence of adverse events such as itching, redness, inflammation etc
arm group label: Treatment group
arm group type: Experimental
description: The patients will be applied 1 mL of solutions(Herbal and Minoxidil) at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
arm group label: Control group
arm group type: Active Comparator
description: The patients will be applied 1 mL of Minoxidil 5% solutions at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks.
intervention type: Drug
intervention name: Topical Herbal Solution
description: Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.
arm group label: Treatment group
intervention type: Drug
intervention name: Topical Minoxidil 5%
description: Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
arm group label: Control group
arm group label: Treatment group
other name: Minoxidil
criteria: 
gender: Male
gender based: Yes
gender description: Healthy men 18 to 50 years old
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farid Masoud, PharmD
role: Principal Investigator
affiliation: Pharmacy Faculty
last name: Yousef Javadzadeh, Ph.D
role: Study Director
affiliation: Department of Pharmaceutics, Pharmacy Faculty
last name: Hamideh Azimi Alamdari, MD
role: Principal Investigator
affiliation: Department of Dermatology, Faculty of Medicine
last name: Solmaz Asnaashari, Ph.D
role: Study Director
affiliation: Department of Pharmacognosy, Pharmacy Faculty
last name: Javad Shokri, Ph.D
role: Study Director
affiliation: Department of Pharmaceutics, Pharmacy Faculty
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Tabriz University of Medical Sciences
investigator full name: Farid Masoud
investigator title: Principal Investigator
mesh term: Alopecia
mesh term: Alopecia Areata
mesh term: Minoxidil
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small numbers of subjects
point of contact: 