<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/NCT01722812</url>
  </required_header>
  <id_info>
    <org_study_id>LP0075-34</org_study_id>
    <nct_id>NCT01722812</nct_id>
  </id_info>
  <brief_title>Cromoglicate in Psoriasis</brief_title>
  <official_title>An Exploratory Study Evaluating the Efficacy of Cromoglicate Cream Compared to Cream Vehicle in the Treatment of Itch in Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LEO Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LEO Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate&#xD;
      cream compared to cream vehicle in the treatment of itch in psoriasis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of change in visual analogue scale</measure>
    <time_frame>Baseline to week 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of change in 4-point itch scale, 7-point itch scale, duration of itch and comparison of treated areas</measure>
    <time_frame>Baseline to week 2</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Placebo (left) / Cromoglicate (right)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placebo (on a lesion on left body side), Cromoglicate (on a lesion on right body side)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (right) / Cromoglicate (left)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Placebo (on a lesion on right body side), Cromoglicate (on a lesion on left body side)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cromoglicate</intervention_name>
    <description>Twice daily topical treatment for 14 days</description>
    <arm_group_label>Placebo (right) / Cromoglicate (left)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Twice daily topical treatment for 14 days</description>
    <arm_group_label>Placebo (left) / Cromoglicate (right)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent has been obtained&#xD;
&#xD;
          -  Age 18 years or above&#xD;
&#xD;
          -  Either sex&#xD;
&#xD;
          -  Any race or ethnicity&#xD;
&#xD;
          -  Attending hospital outpatient clinic or the private practice of a dermatologist&#xD;
&#xD;
          -  Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric&#xD;
             distribution&#xD;
&#xD;
          -  Two treatment areas with a symmetrical distribution each corresponding to 2-3% BSA&#xD;
             (Body Surface Area) and each including at least one itchy psoriasis plaque&#xD;
&#xD;
          -  Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual&#xD;
             Analogue Scale (VAS) with a maximum difference of 10mm on the visual analogue scale&#xD;
             between each of the two treatment areas&#xD;
&#xD;
          -  Disease severity graded mild, moderate or severe according to the Physician's global&#xD;
             assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment&#xD;
             areas. The disease severity must be the same for both treatment areas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic treatment with biological therapies, whether marketed or not, with a possible&#xD;
             effect on psoriasis vulgaris within the following time periods prior to randomisation:&#xD;
&#xD;
               -  etanercept - within 4 weeks prior to randomisation&#xD;
&#xD;
               -  adalimumab, infliximab - within 8 weeks prior to randomisation&#xD;
&#xD;
               -  ustekinumab - within 16 weeks prior to randomisation&#xD;
&#xD;
               -  other products - 4 weeks/5 half-lives (whichever is longer)&#xD;
&#xD;
          -  Systemic treatment with all other therapies with a possible effect on psoriasis&#xD;
             vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin, fumaric acid&#xD;
             derivatives, and other immunosuppressants) within 4 weeks prior to randomization&#xD;
&#xD;
          -  Any topical treatment of the treatment areas (except for emollients) within 2 weeks&#xD;
             prior to randomisation.&#xD;
&#xD;
          -  Treatment with therapies, whether marketed or not, with a possible effect on itch&#xD;
             within the following time periods prior to randomisation:&#xD;
&#xD;
               -  antihistamines - within 1 week prior to randomisation&#xD;
&#xD;
               -  gabapentin - within 4 weeks prior to randomisation&#xD;
&#xD;
          -  Subjects who have received treatment with any non-marketed drug substance (i.e. a drug&#xD;
             which has not yet been made available for clinical use following registration) within&#xD;
             the 4-week period prior to randomisation or longer, if the class of substance required&#xD;
             a longer treatment free period as defined in exclusion criterion 1 for biological&#xD;
             treatments&#xD;
&#xD;
          -  PUVA (Psoralen and Ultraviolet A Radiation) or Grenz ray therapy within 4 weeks prior&#xD;
             to randomisation.&#xD;
&#xD;
          -  UVB therapy within 2 weeks prior to randomisation&#xD;
&#xD;
          -  Planned initiation of, or changes to concomitant medication that could affect&#xD;
             psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium)&#xD;
             within 2 weeks prior to randomisation&#xD;
&#xD;
          -  Subjects with current participation in any other interventional clinical trial&#xD;
&#xD;
          -  Subjects with any of the following conditions present on the treatment areas: viral&#xD;
             (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections,&#xD;
             parasitic infections, skin manifestations in relation to syphilis or tuberculosis,&#xD;
             acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis,&#xD;
             ulcers and wounds&#xD;
&#xD;
          -  Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis)&#xD;
             on the treatment area that may confound the evaluation of psoriasis&#xD;
&#xD;
          -  Subjects with a history of serious allergy, allergic skin rash or sensitivity to any&#xD;
             component of the investigational products or formulations being tested&#xD;
&#xD;
          -  Known or suspected severe renal insufficiency or severe hepatic disorders&#xD;
&#xD;
          -  Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis&#xD;
&#xD;
          -  Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e.,&#xD;
             normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight&#xD;
             or artificial ultraviolet light should be avoided)&#xD;
&#xD;
          -  Subjects previously randomised into this trial&#xD;
&#xD;
          -  Not all of the exclusion criteria listed due to limited space&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>D-10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</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>Cromolyn Sodium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01722812
org study id: LP0075-34
nct id: NCT01722812
lead sponsor: 
has dmc: No
The purpose of this exploratory study is to investigate the clinical efficacy of cromoglicate
      cream compared to cream vehicle in the treatment of itch in psoriasis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of change in visual analogue scale
time frame: Baseline to week 2
measure: Evaluation of change in 4-point itch scale, 7-point itch scale, duration of itch and comparison of treated areas
time frame: Baseline to week 2
arm group label: Placebo (left) / Cromoglicate (right)
arm group type: Other
description: Placebo (on a lesion on left body side), Cromoglicate (on a lesion on right body side)
arm group label: Placebo (right) / Cromoglicate (left)
arm group type: Other
description: Placebo (on a lesion on right body side), Cromoglicate (on a lesion on left body side)
intervention type: Drug
intervention name: Cromoglicate
description: Twice daily topical treatment for 14 days
arm group label: Placebo (right) / Cromoglicate (left)
intervention type: Drug
intervention name: Placebo
description: Twice daily topical treatment for 14 days
arm group label: Placebo (left) / Cromoglicate (right)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Cromolyn Sodium