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/NCT06015152</url>
    </required_header>
    <id_info>
      <org_study_id>NO.F.2-81/2022-GENL/251/JPMC</org_study_id>
      <nct_id>NCT06015152</nct_id>
    </id_info>
    <brief_title>Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis</brief_title>
    <official_title>Comparison Of The Efficacy Of Tazarotene 0.045% Versus Halobetasol Propionate 0.01% Lotion For the Treatment of Scalp Psoriasis</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>
        Psoriasis is a serious, immune-driven illness that affects around 2% of the population and&#xD;
        has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and&#xD;
        topical therapy can be an important part of treatment.&#xD;
  &#xD;
        tazarotene is the first receptor-selective retinoid for the topical treatment of plaque&#xD;
        psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite,&#xD;
        tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic&#xD;
        acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human&#xD;
        epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin.&#xD;
        .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Topical Corticosteroids is commonly used in situations of mild to moderate disease severity.&#xD;
        However, long-term safety is still an issue, especially when utilizing stronger&#xD;
        formulations,which come with a higher risk of local cutaneous adverse events (AEs).&#xD;
        Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin&#xD;
        shrinkage are some of these negative consequences. By regulating gene transcription,&#xD;
        tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal&#xD;
        hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis,&#xD;
        thereby producing a more normal expression of skin differentiation in psoriatic lesions&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">February 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</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>The efficacy of Tazarotene 0.045% in Scalp Psoriasis</measure>
      <time_frame>Efficacy will be assessed after 02 weeks</time_frame>
      <description>Efficacy will be assessed by using Investigator's Global Assessment score for scalp psoriasis which is typically a 5-point scale from 0 to 4, with 0 = Clear/No Disease, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4 = Severe.&#xD;
  Mean diference of IGA score before and after treatment will be calculated</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">90</enrollment>
    <condition>Scalp Psoriasis</condition>
    <arm_group>
      <arm_group_label>GROUP A Tazarotene 0.045%</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.&#xD;
  Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GROUP B Halobetasol Propionate 0.01%</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.&#xD;
  Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.&#xD;
  .</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tazarotene 0.045% Topical Application Lotion [ARAZLO]</intervention_name>
      <description>[ARAZLO]</description>
      <arm_group_label>GROUP A Tazarotene 0.045%</arm_group_label>
      <arm_group_label>GROUP B Halobetasol Propionate 0.01%</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 30-50 years of age, either gender presenting with scalp psoriasis as&#xD;
               per operational definition will be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pustular psoriasis or had used phototherapy, photochemotherapy, or systemic psoriasis&#xD;
               therapy within the last four weeks (or biologics within the last three months).&#xD;
  &#xD;
            -  Used topical treatment within 14 days prior to the baseline visit or who were&#xD;
               diagnosed with skin conditions that would interfere with the interpretation of results&#xD;
               were also excluded.&#xD;
  &#xD;
          pregnant women, women attempting to become pregnant, lactation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 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>KHADIJA ASADULLAH, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>JPMC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>FAIZA 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 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 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>Nazia Jabeen</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>Psoriasis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tazarotene</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/NCT06015152
  org study id: NO.F.2-81/2022-GENL/251/JPMC
  nct id: NCT06015152
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Psoriasis is a serious, immune-driven illness that affects around 2% of the population and
        has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and
        topical therapy can be an important part of treatment.
  
        tazarotene is the first receptor-selective retinoid for the topical treatment of plaque
        psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite,
        tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic
        acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human
        epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin.
        .
  Topical Corticosteroids is commonly used in situations of mild to moderate disease severity.
        However, long-term safety is still an issue, especially when utilizing stronger
        formulations,which come with a higher risk of local cutaneous adverse events (AEs).
        Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin
        shrinkage are some of these negative consequences. By regulating gene transcription,
        tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal
        hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis,
        thereby producing a more normal expression of skin differentiation in psoriatic lesions
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The efficacy of Tazarotene 0.045% in Scalp Psoriasis
  time frame: Efficacy will be assessed after 02 weeks
  description: Efficacy will be assessed by using Investigator's Global Assessment score for scalp psoriasis which is typically a 5-point scale from 0 to 4, with 0 = Clear/No Disease, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4 = Severe.
  Mean diference of IGA score before and after treatment will be calculated
  arm group label: GROUP A Tazarotene 0.045%
  arm group type: Experimental
  description: Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.
  Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.
  arm group label: GROUP B Halobetasol Propionate 0.01%
  arm group type: Experimental
  description: Topical tazarotene 0.045% and halobetasol Propionate 0.01% . TAZ is the first receptor-selective retinoid used externally to treat plaque psoriasis . The major metabolite of tazarotene, tazarotenic acid, is quickly formed after application and binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic acid has a weak affinity for retinoid X receptors and prefers to bind to RARs b and g.
  Halobetasol propionate is a medication used to treat scalp psoriasis. It is a form of topical corticosteroid, which means it works by suppressing the immune system and reducing inflammation.
  .
  intervention type: Drug
  intervention name: Tazarotene 0.045% Topical Application Lotion [ARAZLO]
  description: [ARAZLO]
  arm group label: GROUP A Tazarotene 0.045%
  arm group label: GROUP B Halobetasol Propionate 0.01%
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: PARISA SANAWAR, FCPS
  role: Principal Investigator
  affiliation: JPMC
  last name: KHADIJA ASADULLAH, FCPS
  role: Principal Investigator
  affiliation: JPMC
  last name: FAIZA INAM, FCPS
  role: Principal Investigator
  affiliation: JPMC
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Jinnah Postgraduate Medical Centre
  investigator full name: Nazia Jabeen
  investigator title: Principal Investigator
  mesh term: Psoriasis
  mesh term: Tazarotene