xml: <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/NCT06013540</url>
    </required_header>
    <id_info>
      <org_study_id>NO.F2-81/2022-GENL/255/JPMC</org_study_id>
      <nct_id>NCT06013540</nct_id>
    </id_info>
    <brief_title>Comparison Of Efficacy Of Combination Of TAM Formula Vs Kligman Formula For Melasma.</brief_title>
    <official_title>Comparison Of The Efficacy Of Combination Of TAM Formula Versus Kligman Formula For Melasma At Tertiary Care Hospital,Karachi.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jinnah Postgraduate Medical Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jinnah Postgraduate Medical Centre</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study would offer the participants about the knowledge of these formula in the treatment&#xD;
        of melasma and help the investigators in incorporating and updating the management protocols&#xD;
        in medical practice.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>Phase 2</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA</measure>
      <time_frame>Efficacy will be assesed upto 2 months.</time_frame>
      <description>Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the &quot;area of involvement&quot; is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">122</enrollment>
    <condition>Melasma</condition>
    <arm_group>
      <arm_group_label>Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)</intervention_name>
      <description>TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)</description>
      <arm_group_label>Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)</intervention_name>
      <description>Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)</description>
      <arm_group_label>Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 25-65 years of age, either gender having melasma for over one month&#xD;
               will be included in the study&#xD;
  &#xD;
            -  Exclusion Criteria:&#xD;
  &#xD;
                 -  Pregnancy, breastfeeding, taking birth control pills or plans to become pregnant&#xD;
                    during the study&#xD;
  &#xD;
                 -  History of cutaneous photosensitization, porphyria, and hypersensitivity to&#xD;
                    porphyrins or photodermatosis&#xD;
  &#xD;
                 -  History of skin pathology or condition that could interfere with the evaluation&#xD;
                    or requires the use of interfering topical or systemic therapy&#xD;
  &#xD;
                 -  History of uncorrected coagulation defect or is currently using anti-coagulation&#xD;
                    medication (including but not limited to heavy aspirin therapy)&#xD;
  &#xD;
                 -  History of sensitivity to hydroquinone or Retin-A&#xD;
  &#xD;
                 -  History of evidence of a compromised immune system or hepatitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>JPMC</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jinnah Postgraduate Medical Centre</investigator_affiliation>
      <investigator_full_name>Dr Khadijah Asadullah</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melanosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluocinolone Acetonide</mesh_term>
      <mesh_term>Tretinoin</mesh_term>
      <mesh_term>Hydroquinone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013540
  org study id: NO.F2-81/2022-GENL/255/JPMC
  nct id: NCT06013540
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study would offer the participants about the knowledge of these formula in the treatment
        of melasma and help the investigators in incorporating and updating the management protocols
        in medical practice.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: EFFICACY OF COMBINATION OF TAM FORMULA VERSUS KLIGMAN FORMULA IN TREATMENT OF MELASMA
  time frame: Efficacy will be assesed upto 2 months.
  description: Efficacy will be assessed by using Modified MASI(Melasma Area and Severity Index)In MASI scoring the "area of involvement" is calculated from 0 to 6 while the intensity and homogeneity of pigmentation are scored from 0 to 4 only. (Melasma Area Severity Index)
  arm group label: Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
  arm group type: Experimental
  arm group label: Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
  arm group type: Experimental
  intervention type: Combination Product
  intervention name: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
  description: TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
  arm group label: Group A TAM formula (hydroquinone 2%, tretinoin 0.05% and 5% vitamin C)
  intervention type: Combination Product
  intervention name: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
  description: Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
  arm group label: Group B Kligman formula (hydroquinone 4%, fluocinolone acetonide 0.01% and tretinoin 0.05%)
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Jinnah Postgraduate Medical Centre
  investigator full name: Dr Khadijah Asadullah
  investigator title: Principal Investigator
  mesh term: Melanosis
  mesh term: Fluocinolone Acetonide
  mesh term: Tretinoin
  mesh term: Hydroquinone