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/NCT06042647</url>
    </required_header>
    <id_info>
      <org_study_id>DCS-69-22</org_study_id>
      <nct_id>NCT06042647</nct_id>
    </id_info>
    <brief_title>Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis</brief_title>
    <official_title>A Demonstration of the Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion as Compared to 0.05% Clobetasol Propionate Cream in the Treatment of Psoriasis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dermatology Consulting Services, PLLC</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dermatology Consulting Services, PLLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this research is to demonstrate superior anti-inflammatory effects, as&#xD;
        demonstrated by a reduction in TNF-a and IL-17A, with tazarotene/halobetasol lotion in&#xD;
        patients with mild to moderate plaque type psoriasis as compared to clobetasol propionate&#xD;
        0.05% cream.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Male or female subjects with mild to moderate plaque type psoriasis will present to the&#xD;
        research center for evaluation for study entry. They will have been advised to present to the&#xD;
        research center with clean skin and no topical products applied to the body, including&#xD;
        medications, moisturizers, sunscreens, etc. If found to be suitable by meeting all inclusion&#xD;
        criteria and none of the exclusion criteria, subjects will undergo selection of 2 target&#xD;
        plaques by the dermatologist investigator. Each plaque will be graded for erythema, scaling,&#xD;
        and induration. An Investigational Global Assessment (IGA) score will be assigned for each&#xD;
        plaque. Plaques must have an IGA of mild (2) or moderate (3) to qualify for inclusion. The&#xD;
        subjects will also assess each plaque for redness, thickness, and scaling. Each of the&#xD;
        plaques will be photographed.The subjects will undergo D-squame tape strip removal of each of&#xD;
        the 2 target psoriasis plaques. One plaque will serve as the tazarotene/halobetasol lotion&#xD;
        treated plaque and the other will serve as the clobetasol propionate 0.05% cream treated&#xD;
        plaque. 10 D-squames will be obtained with from each plaque. 5 tape strips will be placed in&#xD;
        each glass jar. One jar will contain the even tape strips and the other jar will contain the&#xD;
        odd tape strips. 10 D-squames will also be taken from normal skin to serve as a negative&#xD;
        control in an individual without psoriasis. 5 tape strips will be placed in each glass jar.&#xD;
        One jar will contain the even tape strips and the other jar will contain the odd tape strips.&#xD;
        The D-squames will be frozen in a -80C freezer for later assessment. Five tape strips will be&#xD;
        analyzed together to obtain adequate material for ELISA analysis. Two specimens jars will be&#xD;
        prepared for from each of the 2 target plaques. One jar will be analyzed with the second jar&#xD;
        serving as a back up.The subjects will have a number assigned to each of the treatment&#xD;
        plaques. The numbers will be recorded on a body map. Two copies will be prepared. One copy&#xD;
        will remain at the research center and the second copy will be provided to the subject. Each&#xD;
        subject will receive one tube of tazarotene/halobetasol lotion for application to one&#xD;
        randomized target plaque and a tube of clobetasol propionate 0.05% cream to apply the second&#xD;
        randomized target plaque.Subjects will be provided with a diary. They will be instructed to&#xD;
        apply the study product at bedtime to the designated target plaque. Care must be taken to&#xD;
        apply the proper product to the proper plaque. Subjects will be instructed to return to the&#xD;
        research center in 4 weeks. A reminder text for compliance will be provided prior to the week&#xD;
        4 visit.Subjects will return to the research center at week 4. The dermatologist investigator&#xD;
        will evaluate each plaque for erythema, scaling, and induration. An Investigational Global&#xD;
        Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each&#xD;
        plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The&#xD;
        subjects will undergo D-squame tape strip removal of 10 tape strips for each of the 2 target&#xD;
        psoriasis plaques. Five tape strips will be placed in each jar with one jar receiving the&#xD;
        even tape strips and the other jar receiving the odd tape strips. The D-squames will be&#xD;
        frozen in a -80C freezer for later assessment. Subjects will discontinue treatment of the&#xD;
        plaques at this time. All medication and study diaries will be collected. Subjects will be&#xD;
        asked to return to the research center at week 8. A reminder text for compliance will be sent&#xD;
        prior to the week 8 visit.Subjects will return to the research center at week 8. No treatment&#xD;
        will be applied to the target plaques for the past 4 weeks. The dermatologist investigator&#xD;
        will evaluate each plaque for erythema, scaling, and induration. An Investigational Global&#xD;
        Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each&#xD;
        plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The&#xD;
        subjects will undergo D-squame tape strip removal 10 times for each of the 2 target psoriasis&#xD;
        plaques. Five tape strips will be placed in each jar with one jar containing the even tape&#xD;
        strips and the other jar containing the odd tape strips. The D-squames will be frozen in a&#xD;
        -80C freezer for later assessment. Subjects will complete their study participation at this&#xD;
        time.The D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present&#xD;
        after 4 weeks of treatment with tazarotene/halobetasol lotion to one randomized target plaque&#xD;
        and clobetasol propionate 0.05% cream to apply the second randomized target plaque. Treatment&#xD;
        will be discontinued at week 4 and subjects will remain untreated for the subsequent 4 weeks.&#xD;
        At week 8, D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present&#xD;
        after 4 weeks off treatment with tazarotene/halobetasol lotion to one randomized target&#xD;
        plaque and clobetasol propionate 0.05% cream to apply the second randomized target plaque.&#xD;
        This research will allow comparison between a retinoid/topical corticosteroid combination and&#xD;
        a topical corticosteroid alone in terms of inflammatory mediator reduction. It will also&#xD;
        provide insight into the ability of a retinoid/topical corticosteroid combination to produce&#xD;
        longer lasting inflammatory mediator reduction than a topical corticosteroid alone.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>One product applied to psoriasis on the right side of the body and a second product applied to the left side of the body. The right and left side product applications will be randomized.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Investigator will not know which product is applied to the right and left psoriasis target plaque.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Concentration of TNF-a and IL-17A in Psoriatic Plaques</measure>
      <time_frame>8 weeks</time_frame>
      <description>The primary outcome is to compare the concentration of TNF-a and/or IL-17A after discontinuing treatment for 4 weeks with tazarotene/halobetasol lotion as compared to clobetasol propionate 0.05% cream.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Psoriasis Vulgaris</condition>
    <arm_group>
      <arm_group_label>0.01% Halobetasol and 0.045% Tazarotene Lotion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Clobetasol Propionate 0.05% Cream (generic)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Clobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.01% Halobetasol</intervention_name>
      <description>Drug to be applied at bedtime to designated target psoriasis plaque at bedtime.</description>
      <arm_group_label>0.01% Halobetasol and 0.045% Tazarotene Lotion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.045% Tazarotene</intervention_name>
      <description>Drug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime.</description>
      <arm_group_label>0.01% Halobetasol and 0.045% Tazarotene Lotion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.05% Clobetasol Propionate</intervention_name>
      <description>Drug to be applied to designated psoriatic plaque at bedtime.</description>
      <arm_group_label>Clobetasol Propionate 0.05% Cream (generic)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or non-pregnant females 18+ years of age.&#xD;
  &#xD;
            2. Plaque type mild to moderate psoriasis suitable for topical treatment.&#xD;
  &#xD;
            3. The presence of 2 plaques suitable for tape stripping&#xD;
  &#xD;
            4. Subjects must be willing to allow a series of tape pieces to be pressed and removed&#xD;
               from 2 target psoriasis plaques.&#xD;
  &#xD;
            5. Subjects must be in general good health as determined from a medical history.&#xD;
  &#xD;
            6. Subjects must read and sign the informed consent form after the nature of the study&#xD;
               has been fully explained.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with known allergies or sensitivities to ingredients contained in the test&#xD;
               products.&#xD;
  &#xD;
            2. Subjects with an allergy to latex or adhesives.&#xD;
  &#xD;
            3. Subjects with pustular or erythrodermic psoriasis.&#xD;
  &#xD;
            4. Subjects who are pregnant or nursing or planning to become pregnant during the course&#xD;
               of the study.&#xD;
  &#xD;
            5. Subjects who are currently participating in any other clinical study (i.e., dermal&#xD;
               patch, use tests, investigational drug or devices, etc.).&#xD;
  &#xD;
            6. Subjects viewed by the investigator as not being able to complete the study.&#xD;
  &#xD;
            7. Subjects using any type of lotion, medication, or other topical product to the&#xD;
               psoriasis plaques.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dermatology Consulting Services, PLLC</name>
        <address>
          <city>High Point</city>
          <state>North Carolina</state>
          <zip>27262</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 16, 2023</last_update_submitted>
    <last_update_submitted_qc>September 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>Clobetasol</mesh_term>
      <mesh_term>Halobetasol</mesh_term>
      <mesh_term>Tazarotene</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06042647
  org study id: DCS-69-22
  nct id: NCT06042647
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The objective of this research is to demonstrate superior anti-inflammatory effects, as
        demonstrated by a reduction in TNF-a and IL-17A, with tazarotene/halobetasol lotion in
        patients with mild to moderate plaque type psoriasis as compared to clobetasol propionate
        0.05% cream.
  Male or female subjects with mild to moderate plaque type psoriasis will present to the
        research center for evaluation for study entry. They will have been advised to present to the
        research center with clean skin and no topical products applied to the body, including
        medications, moisturizers, sunscreens, etc. If found to be suitable by meeting all inclusion
        criteria and none of the exclusion criteria, subjects will undergo selection of 2 target
        plaques by the dermatologist investigator. Each plaque will be graded for erythema, scaling,
        and induration. An Investigational Global Assessment (IGA) score will be assigned for each
        plaque. Plaques must have an IGA of mild (2) or moderate (3) to qualify for inclusion. The
        subjects will also assess each plaque for redness, thickness, and scaling. Each of the
        plaques will be photographed.The subjects will undergo D-squame tape strip removal of each of
        the 2 target psoriasis plaques. One plaque will serve as the tazarotene/halobetasol lotion
        treated plaque and the other will serve as the clobetasol propionate 0.05% cream treated
        plaque. 10 D-squames will be obtained with from each plaque. 5 tape strips will be placed in
        each glass jar. One jar will contain the even tape strips and the other jar will contain the
        odd tape strips. 10 D-squames will also be taken from normal skin to serve as a negative
        control in an individual without psoriasis. 5 tape strips will be placed in each glass jar.
        One jar will contain the even tape strips and the other jar will contain the odd tape strips.
        The D-squames will be frozen in a -80C freezer for later assessment. Five tape strips will be
        analyzed together to obtain adequate material for ELISA analysis. Two specimens jars will be
        prepared for from each of the 2 target plaques. One jar will be analyzed with the second jar
        serving as a back up.The subjects will have a number assigned to each of the treatment
        plaques. The numbers will be recorded on a body map. Two copies will be prepared. One copy
        will remain at the research center and the second copy will be provided to the subject. Each
        subject will receive one tube of tazarotene/halobetasol lotion for application to one
        randomized target plaque and a tube of clobetasol propionate 0.05% cream to apply the second
        randomized target plaque.Subjects will be provided with a diary. They will be instructed to
        apply the study product at bedtime to the designated target plaque. Care must be taken to
        apply the proper product to the proper plaque. Subjects will be instructed to return to the
        research center in 4 weeks. A reminder text for compliance will be provided prior to the week
        4 visit.Subjects will return to the research center at week 4. The dermatologist investigator
        will evaluate each plaque for erythema, scaling, and induration. An Investigational Global
        Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each
        plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The
        subjects will undergo D-squame tape strip removal of 10 tape strips for each of the 2 target
        psoriasis plaques. Five tape strips will be placed in each jar with one jar receiving the
        even tape strips and the other jar receiving the odd tape strips. The D-squames will be
        frozen in a -80C freezer for later assessment. Subjects will discontinue treatment of the
        plaques at this time. All medication and study diaries will be collected. Subjects will be
        asked to return to the research center at week 8. A reminder text for compliance will be sent
        prior to the week 8 visit.Subjects will return to the research center at week 8. No treatment
        will be applied to the target plaques for the past 4 weeks. The dermatologist investigator
        will evaluate each plaque for erythema, scaling, and induration. An Investigational Global
        Assessment (IGA) score will be assigned for each plaque. The subjects will also assess each
        plaque for redness, thickness, and scaling. Each of the plaques will be photographed. The
        subjects will undergo D-squame tape strip removal 10 times for each of the 2 target psoriasis
        plaques. Five tape strips will be placed in each jar with one jar containing the even tape
        strips and the other jar containing the odd tape strips. The D-squames will be frozen in a
        -80C freezer for later assessment. Subjects will complete their study participation at this
        time.The D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present
        after 4 weeks of treatment with tazarotene/halobetasol lotion to one randomized target plaque
        and clobetasol propionate 0.05% cream to apply the second randomized target plaque. Treatment
        will be discontinued at week 4 and subjects will remain untreated for the subsequent 4 weeks.
        At week 8, D-squames will be analyzed using ELISA for the amount of TNF-a and IL-17A present
        after 4 weeks off treatment with tazarotene/halobetasol lotion to one randomized target
        plaque and clobetasol propionate 0.05% cream to apply the second randomized target plaque.
        This research will allow comparison between a retinoid/topical corticosteroid combination and
        a topical corticosteroid alone in terms of inflammatory mediator reduction. It will also
        provide insight into the ability of a retinoid/topical corticosteroid combination to produce
        longer lasting inflammatory mediator reduction than a topical corticosteroid alone.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: One product applied to psoriasis on the right side of the body and a second product applied to the left side of the body. The right and left side product applications will be randomized.
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Investigator will not know which product is applied to the right and left psoriasis target plaque.
  measure: Concentration of TNF-a and IL-17A in Psoriatic Plaques
  time frame: 8 weeks
  description: The primary outcome is to compare the concentration of TNF-a and/or IL-17A after discontinuing treatment for 4 weeks with tazarotene/halobetasol lotion as compared to clobetasol propionate 0.05% cream.
  arm group label: 0.01% Halobetasol and 0.045% Tazarotene Lotion
  arm group type: Active Comparator
  description: 0.01% Halobetasol and 0.045% Tazarotene Lotion (Duobrii)Applied to designated target plaque at bedtime.
  arm group label: Clobetasol Propionate 0.05% Cream (generic)
  arm group type: Active Comparator
  description: Clobetasol Propionate 0.05% Cream (generic)Applied to designated target plaque at bedtime.
  intervention type: Drug
  intervention name: 0.01% Halobetasol
  description: Drug to be applied at bedtime to designated target psoriasis plaque at bedtime.
  arm group label: 0.01% Halobetasol and 0.045% Tazarotene Lotion
  intervention type: Drug
  intervention name: 0.045% Tazarotene
  description: Drug to be applied in combination with 0.01% Halobetasol to the designated psoriasis plaque at bedtime.
  arm group label: 0.01% Halobetasol and 0.045% Tazarotene Lotion
  intervention type: Drug
  intervention name: 0.05% Clobetasol Propionate
  description: Drug to be applied to designated psoriatic plaque at bedtime.
  arm group label: Clobetasol Propionate 0.05% Cream (generic)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Psoriasis
  mesh term: Clobetasol
  mesh term: Halobetasol
  mesh term: Tazarotene
  sharing ipd: No