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/NCT06008327</url>
    </required_header>
    <id_info>
      <org_study_id>NO.F2-81/2022-GENL/254/JPMC</org_study_id>
      <nct_id>NCT06008327</nct_id>
    </id_info>
    <brief_title>Comparison Of Outcome Of Treatment OF Topical 15%TCA VS Topical 0.05% Tretinoin In Treatment Of Acanthosis Nigricans</brief_title>
    <official_title>Comparison Of The Outcome Of Treatment Of Topical 15% Trichloroacetic Acid Versus Topical 0.05% Tretinoin In The Treatment Of Acanthosis Nigricans</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by&#xD;
        the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in&#xD;
        intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent&#xD;
        has shown efficacy in treating acanthosis nigricans. Data from this would help in&#xD;
        establishing it as a treatment of choice thereby lead to reduction in cost and benefit the&#xD;
        patient both financially and psychologically.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acanthosis nigricans is common, although exact prevalence depends upon the racial makeup of&#xD;
        the population studied. Exact pathogenesis is unknown, elevated insulin concentrations result&#xD;
        in direct and indirect activation of IGF-1 receptors on keratinocytes and fibroblasts,&#xD;
        leading to proliferation. This hyperpigmentation, which has poorly defined borders, usually&#xD;
        occurs in skin fold areas symmetrically, such as the back of the neck, axilla and groin, and&#xD;
        may rarely involve oral mucosa. The lesions may be related to a wide range of benign&#xD;
        conditions and may occur as a paraneoplastic manifestation of various potentially fatal&#xD;
        malignancies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">June 20, 2023</completion_date>
    <primary_completion_date type="Actual">June 20, 2023</primary_completion_date>
    <phase>N/A</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 TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS</measure>
      <time_frame>It will be assessed upto 02 months</time_frame>
      <description>Efficacy will be assessed by taking serials photographs before and after treatment shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Acanthosis Nigricans</condition>
    <arm_group>
      <arm_group_label>Group A Topical 15% Trichloroacetic acid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>15 % Trichloroacetic acid (TCA) and 0.05%Tretinoin for 02 months Trichloroacetic acid, a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. 9-10 Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B Topical 0.05% Tretinoin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical tretinoin is the first choice of drug in the treatment of acanthosis nigricans. Despite several therapeutic modalities, acanthosis nigricans (AN) remains a difficult dermatosis to treat.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topical 15% Trichloroacetic acid</intervention_name>
      <description>Recently trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.</description>
      <arm_group_label>Group A Topical 15% Trichloroacetic acid</arm_group_label>
      <arm_group_label>Group B Topical 0.05% Tretinoin</arm_group_label>
      <other_name>Topical 0.05% Tretinoin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who will present with acanthosis nigricans as per operational definition will&#xD;
               be included in the study.&#xD;
  &#xD;
                 -  Either gender.&#xD;
  &#xD;
                 -  Age 20-50 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnancy.&#xD;
  &#xD;
            -  Breastfeeding.&#xD;
  &#xD;
            -  Patients with history of skin resurfacing by dermabrasion, chemical peels and facial&#xD;
               laser within the preceding 9 months.&#xD;
  &#xD;
            -  Patients with history of hypersensitivity.&#xD;
  &#xD;
            -  Malignant Acanthosis Nigricans.&#xD;
  &#xD;
            -  Drug Induced Acanthosis Nigricans.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Parisa Sanawar, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jpmc</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nazia Jabeen, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jpmc</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fazia Inam, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jpmc</affiliation>
    </overall_official>
    <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 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 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</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>Acanthosis Nigricans</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tretinoin</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/NCT06008327
  org study id: NO.F2-81/2022-GENL/254/JPMC
  nct id: NCT06008327
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Acanthosis nigricans (AN) is a dermatosis with aesthetic implications and is characterized by
        the focal or diffuse development of a velvety, hyperpigmented cutaneous thickening in
        intertriginous areas. Trichloroacetic acid (TCA), a superficial chemical exfoliative agent
        has shown efficacy in treating acanthosis nigricans. Data from this would help in
        establishing it as a treatment of choice thereby lead to reduction in cost and benefit the
        patient both financially and psychologically.
  Acanthosis nigricans is common, although exact prevalence depends upon the racial makeup of
        the population studied. Exact pathogenesis is unknown, elevated insulin concentrations result
        in direct and indirect activation of IGF-1 receptors on keratinocytes and fibroblasts,
        leading to proliferation. This hyperpigmentation, which has poorly defined borders, usually
        occurs in skin fold areas symmetrically, such as the back of the neck, axilla and groin, and
        may rarely involve oral mucosa. The lesions may be related to a wide range of benign
        conditions and may occur as a paraneoplastic manifestation of various potentially fatal
        malignancies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: EFFICACY OF TOPICAL 15%TRICHLOROACETIC ACID VERSUS 0.05% TOPICAL TRETINOIN IN ACANTHOSIS NIGRICANS
  time frame: It will be assessed upto 02 months
  description: Efficacy will be assessed by taking serials photographs before and after treatment shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.
  arm group label: Group A Topical 15% Trichloroacetic acid
  arm group type: Experimental
  description: 15 % Trichloroacetic acid (TCA) and 0.05%Tretinoin for 02 months Trichloroacetic acid, a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. 9-10 Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.
  arm group label: Group B Topical 0.05% Tretinoin
  arm group type: Experimental
  description: Topical tretinoin is the first choice of drug in the treatment of acanthosis nigricans. Despite several therapeutic modalities, acanthosis nigricans (AN) remains a difficult dermatosis to treat.
  intervention type: Drug
  intervention name: Topical 15% Trichloroacetic acid
  description: Recently trichloroacetic acid (TCA), a superficial chemical exfoliative agent has shown efficacy in treating acanthosis nigricans. Data from this would help in establishing it as a treatment of choice thereby lead to reduction in cost and benefit the patient both financially and psychologically.
  arm group label: Group A Topical 15% Trichloroacetic acid
  arm group label: Group B Topical 0.05% Tretinoin
  other name: Topical 0.05% Tretinoin
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Parisa Sanawar, FCPS
  role: Principal Investigator
  affiliation: Jpmc
  last name: Nazia Jabeen, FCPS
  role: Principal Investigator
  affiliation: Jpmc
  last name: Fazia Inam, FCPS
  role: Principal Investigator
  affiliation: Jpmc
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Jinnah Postgraduate Medical Centre
  investigator full name: Dr Khadijah
  investigator title: Principal Investigator
  mesh term: Acanthosis Nigricans
  mesh term: Tretinoin