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/NCT06011083</url>
    </required_header>
    <id_info>
      <org_study_id>psoriasis vulgaris</org_study_id>
      <nct_id>NCT06011083</nct_id>
    </id_info>
    <brief_title>Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis</brief_title>
    <official_title>Calcipotriol /Betamethasone Ointment Versus Fractional CO2 Laser Plus Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis: Randomized Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone&#xD;
        dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the&#xD;
        same topical ointment containing these two ingredients as treatment modalities for plaque&#xD;
        psoriasis. Additionally, looking into how both therapy modalities affect individuals with&#xD;
        psoriasis in terms of how their quality of life is improved.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at&#xD;
        any age and places a heavy strain on both the individual and society. It is linked to a&#xD;
        number of serious medical disorders, such as cardiometabolic syndrome, depression, and&#xD;
        psoriatic arthritis (1).&#xD;
  &#xD;
        Patients with psoriasis indicate that the condition interferes with their ability to sleep&#xD;
        and rest, limits their everyday activities, particularly their mobility, and stigmatises them&#xD;
        and causes problems in their social lives. Additionally, psoriasis can negatively impact&#xD;
        mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2,&#xD;
        3).&#xD;
  &#xD;
        Topical medicines continue to be the basis of treatment for those with mild psoriasis, and&#xD;
        they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and&#xD;
        keratolytics (4).&#xD;
  &#xD;
        For the topical management of mild psoriasis, preparations containing calcipotriol in&#xD;
        combination with betamethasone (in the form of betamethasone dipropionate) are available (5).&#xD;
        In comparison to the effects of these active substances when given separately,&#xD;
        pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and&#xD;
        immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic&#xD;
        activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations&#xD;
        successful. Betamethasone impacts inflammatory processes and lessens skin irritation and&#xD;
        pruritus following calcipotriol administration, while calcipotriol alters keratinocyte&#xD;
        differentiation (7).&#xD;
  &#xD;
        Fractional lasers were used in the treatment of dermatological diseases. They create tiny&#xD;
        ablation channels in the skin that act as shunts for topically applied medications,&#xD;
        particularly those with high molecular weights (8), by ablation of the skin in the form of&#xD;
        fractions and splitting laser beams into microbeams (9).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">August 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 28, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups.</measure>
      <time_frame>6 month</time_frame>
      <description>Group A included 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm applied twice daily as a monotherapy for 3 months over a selected psoriatic plaque while Group B included 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same topical ointment twice daily for 3 months over a similar psoriatic plaque [as regard anatomical site, size and TES (thickness, erythema, scales) score].&#xD;
  We used a physician-based, four-point scoring system in which the thickness, erythema, and scale within each plaque was rated from 0 (none) to 3 (severe) to evaluate the changes in the severity of individual psoriatic plaques before treatment and with each visit till the end of the treatment course. The TES score is the sum of the scores given to each individual parameter (thickness, erythema and scale)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.</measure>
      <time_frame>6 month</time_frame>
      <description>Dermatology Life Quality Index (DLQI) is used for quality of life assessment. The DLQI is a validated, 10-question, self-reported questionnaire. It was done to evaluate the patient's perception of the impact of psoriasis on quality of life before and at the end of the treatment course of both groups (14, 15). The DLQI questionnaire was divided into 6 commonly identified categories. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life (16). According to the score of the DLQI the impact of psoriasis on QOL is then graded into: no effect at all on patient's life (0-1), small effect (2-5), moderate effect (6-10), very large effect (11-20) and extremely large effect on patient's life (21-30).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Psoriasis Vulgaris</condition>
    <condition>Fractional CO2 Laser</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm twice daily as a monotherapy for 3 months over a selected psoriatic plaque</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same Topical Ointment twice daily for 3 months over a similar psoriatic plaque</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm</intervention_name>
      <description>using topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fractional carbon dioxide (CO2) laser</intervention_name>
      <description>fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with chronic plaque psoriasis of either sex.&#xD;
  &#xD;
            -  Aged more than 18 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant and lactating women.&#xD;
  &#xD;
            -  Patients with severe skin infection.&#xD;
  &#xD;
            -  Patients who are under systemic ttt or phototherapy in the last 3 months.&#xD;
  &#xD;
            -  Immunosuppression or being under any kind of treatment causingabsolute or relative&#xD;
               immunosuppression&#xD;
  &#xD;
            -  History of any bleeding, clotting disorder or using anticoagulants.&#xD;
  &#xD;
            -  Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and&#xD;
               cardiovascular disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Assiut University</name>
        <address>
          <city>Assiut</city>
          <zip>71511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.</citation>
      <PMID>33812489</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Heba Hasan Sayed</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <keyword>psoriasis vulgaris</keyword>
    <keyword>fractional CO2 laser</keyword>
    <keyword>Calcipotriol /Betamethasone Ointment</keyword>
    <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>Betamethasone</mesh_term>
      <mesh_term>Betamethasone Valerate</mesh_term>
      <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
      <mesh_term>Betamethasone benzoate</mesh_term>
      <mesh_term>Calcipotriene</mesh_term>
      <mesh_term>Betamethasone sodium phosphate</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/NCT06011083
  org study id: psoriasis vulgaris
  nct id: NCT06011083
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone
        dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the
        same topical ointment containing these two ingredients as treatment modalities for plaque
        psoriasis. Additionally, looking into how both therapy modalities affect individuals with
        psoriasis in terms of how their quality of life is improved.
  Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at
        any age and places a heavy strain on both the individual and society. It is linked to a
        number of serious medical disorders, such as cardiometabolic syndrome, depression, and
        psoriatic arthritis (1).
  
        Patients with psoriasis indicate that the condition interferes with their ability to sleep
        and rest, limits their everyday activities, particularly their mobility, and stigmatises them
        and causes problems in their social lives. Additionally, psoriasis can negatively impact
        mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2,
        3).
  
        Topical medicines continue to be the basis of treatment for those with mild psoriasis, and
        they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and
        keratolytics (4).
  
        For the topical management of mild psoriasis, preparations containing calcipotriol in
        combination with betamethasone (in the form of betamethasone dipropionate) are available (5).
        In comparison to the effects of these active substances when given separately,
        pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and
        immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic
        activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations
        successful. Betamethasone impacts inflammatory processes and lessens skin irritation and
        pruritus following calcipotriol administration, while calcipotriol alters keratinocyte
        differentiation (7).
  
        Fractional lasers were used in the treatment of dermatological diseases. They create tiny
        ablation channels in the skin that act as shunts for topically applied medications,
        particularly those with high molecular weights (8), by ablation of the skin in the form of
        fractions and splitting laser beams into microbeams (9).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Evaluating the reduction in the severity of the treated psoriatic plaques using Psoriasis severity (TES) score before treatment and after the treatment course in both groups.
  time frame: 6 month
  description: Group A included 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm applied twice daily as a monotherapy for 3 months over a selected psoriatic plaque while Group B included 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same topical ointment twice daily for 3 months over a similar psoriatic plaque [as regard anatomical site, size and TES (thickness, erythema, scales) score].
  We used a physician-based, four-point scoring system in which the thickness, erythema, and scale within each plaque was rated from 0 (none) to 3 (severe) to evaluate the changes in the severity of individual psoriatic plaques before treatment and with each visit till the end of the treatment course. The TES score is the sum of the scores given to each individual parameter (thickness, erythema and scale)
  measure: to look into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.
  time frame: 6 month
  description: Dermatology Life Quality Index (DLQI) is used for quality of life assessment. The DLQI is a validated, 10-question, self-reported questionnaire. It was done to evaluate the patient's perception of the impact of psoriasis on quality of life before and at the end of the treatment course of both groups (14, 15). The DLQI questionnaire was divided into 6 commonly identified categories. The DLQI was rated on a 4-point scale (0 = not at all to 3 = very much). The highest possible total score for the DLQI is 30 and higher scores indicate more severe impact on quality of life (16). According to the score of the DLQI the impact of psoriasis on QOL is then graded into: no effect at all on patient's life (0-1), small effect (2-5), moderate effect (6-10), very large effect (11-20) and extremely large effect on patient's life (21-30).
  arm group label: Group A
  arm group type: Active Comparator
  description: 20 patients who were treated with Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm twice daily as a monotherapy for 3 months over a selected psoriatic plaque
  arm group label: Group B
  arm group type: Active Comparator
  description: 20 patients who were treated with fractional CO2 laser sessions once per month followed by application of the same Topical Ointment twice daily for 3 months over a similar psoriatic plaque
  intervention type: Drug
  intervention name: Topical Ointment containing Calcipotriol 0.05 mg/gm and Betamethasone dipropionate 0.5 mg/gm
  description: using topical ointment containing calcipotriol and betamethasone dipropionate for plaque psoriasis.
  arm group label: Group A
  arm group label: Group B
  intervention type: Device
  intervention name: Fractional carbon dioxide (CO2) laser
  description: fractional CO2 laser sessions once per month for 3 months over a similar psoriatic plaque
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  citation: Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021 Apr 3;397(10281):1301-1315. doi: 10.1016/S0140-6736(20)32549-6.
  PMID: 33812489
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Heba Hasan Sayed
  investigator title: Doctor
  mesh term: Psoriasis
  mesh term: Betamethasone
  mesh term: Betamethasone Valerate
  mesh term: Betamethasone-17,21-dipropionate
  mesh term: Betamethasone benzoate
  mesh term: Calcipotriene
  mesh term: Betamethasone sodium phosphate