<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/NCT01701843</url>
  </required_header>
  <id_info>
    <org_study_id>LP0074-33</org_study_id>
    <nct_id>NCT01701843</nct_id>
  </id_info>
  <brief_title>Cromoglicate in Mastocytosis</brief_title>
  <official_title>A Phase II Exploratory Study Evaluating the Efficacy of Topical Cromoglicate Solution Compared to Topical Solution Vehicle in the Treatment of Mastocytosis</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 study drug&#xD;
      (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right&#xD;
      comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded,&#xD;
      randomised, single centre setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    prematurely terminated because of low recruitment&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 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 mechanically induced changes of lesions</measure>
    <time_frame>Baseline to week 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of mechanically induced wheal and flare response</measure>
    <time_frame>Baseline to week 2</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Mastocytosis</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 left bodyside), Cromoglicate (on a lesion on right bodyside)</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 right bodyside), Cromoglicate (on a lesion on left bodyside)</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 (left) / Cromoglicate (right)</arm_group_label>
    <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>
    <arm_group_label>Placebo (right) / Cromoglicate (left)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent has been obtained&#xD;
&#xD;
          -  Chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic&#xD;
             mastocytosis with skin involvement and a positive Darier's Sign&#xD;
&#xD;
          -  Age between 18 and 70 years&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of autoimmune and infectious disease including aggressive systemic&#xD;
             mastocytosis&#xD;
&#xD;
          -  Medical history or presence of epilepsy, significant neurological disorders,&#xD;
             cerebrovascular attacks or ischemia&#xD;
&#xD;
          -  Medical history or presence of myocardial infarction or cardiac arrhythmia which&#xD;
             requires drug therapy, hyper/hypokalemia&#xD;
&#xD;
          -  Evidence of severe renal dysfunction (creatinine &gt; 1,5 times upper reference value)&#xD;
&#xD;
          -  Evidence of significant hepatic disease (liver enzymes &gt; 2 times upper reference&#xD;
             value)&#xD;
&#xD;
          -  Presence of active cancer which requires chemotherapy or radiation therapy&#xD;
&#xD;
          -  Commitment to an institution in terms of § 40 Abs. 1 S. 3 Nr. 4 AMG&#xD;
&#xD;
          -  Intake of antihistamines or leukotriene antagonists within 7 days prior to the&#xD;
             beginning of the study&#xD;
&#xD;
          -  Intake of oral corticosteroids within 14 days prior to randomisation&#xD;
&#xD;
          -  Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior&#xD;
             to randomisation&#xD;
&#xD;
          -  Radiation therapy of target areas including UV therapy within 4 weeks prior to&#xD;
             randomisation&#xD;
&#xD;
          -  Confounding other dermatological diseases or conditions that can affect the symptoms&#xD;
             of the target areas&#xD;
&#xD;
          -  Known or suspected hypersensitivity to component(s) of investigational products.&#xD;
&#xD;
          -  Current participation in any other interventional clinical trial.&#xD;
&#xD;
          -  Subjects who have received treatment with any nonmarketed drug substance (i.e. an&#xD;
             agent which has not yet been made available for clinical use following registration)&#xD;
             within the last 4 weeks or 5 half-lives (whichever is longer) prior to randomisation&#xD;
&#xD;
          -  Previously randomised in this clinical trial&#xD;
&#xD;
          -  In the opinion of the investigator, the subject is unlikely to comply with the&#xD;
             Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).&#xD;
&#xD;
          -  Females who are pregnant, of child-bearing potential and wishing to become pregnant&#xD;
             during the trial or are breast feeding.&#xD;
&#xD;
          -  Females of child-bearing potential with positive pregnancy test at visit 1.&#xD;
&#xD;
          -  Subjects (or their partner) not using an adequate method of contraception (according&#xD;
             to national requirements, as applicable)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Siebenhaar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergie-Centrum-Charité</affiliation>
  </overall_official>
  <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>March 2013</verification_date>
  <study_first_submitted>July 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>March 6, 2013</last_update_submitted>
  <last_update_submitted_qc>March 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 7, 2013</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>Mastocytosis</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/NCT01701843
org study id: LP0074-33
nct id: NCT01701843
lead sponsor: 
has dmc: No
The purpose of this exploratory study is to investigate the clinical efficacy of study drug
      (LP0074) in the treatment of Mastocytosis. The trial will be performed as a left/right
      comparison study in male/female subjects with mastocytosis, in a prospective, double-blinded,
      randomised, single centre setting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of mechanically induced changes of lesions
time frame: Baseline to week 2
measure: Evaluation of mechanically induced wheal and flare response
time frame: Baseline to week 2
arm group label: Placebo (left) / Cromoglicate (right)
arm group type: Other
description: Placebo (on a lesion left bodyside), Cromoglicate (on a lesion on right bodyside)
arm group label: Placebo (right) / Cromoglicate (left)
arm group type: Other
description: Placebo (on a lesion right bodyside), Cromoglicate (on a lesion on left bodyside)
intervention type: Drug
intervention name: Cromoglicate
description: Twice daily topical treatment for 14 days
arm group label: Placebo (left) / Cromoglicate (right)
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)
arm group label: Placebo (right) / Cromoglicate (left)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Frank Siebenhaar, MD
role: Principal Investigator
affiliation: Allergie-Centrum-Charité
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Mastocytosis
mesh term: Cromolyn Sodium