<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/NCT03834935</url>
  </required_header>
  <id_info>
    <org_study_id>USJDERM1</org_study_id>
    <nct_id>NCT03834935</nct_id>
  </id_info>
  <brief_title>Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba</brief_title>
  <official_title>Efficacy of Topical Pimecrolimus in the Treatment of Pityriasis Alba: A Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Joseph University, Beirut, Lebanon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St Joseph University, Beirut, Lebanon</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and&#xD;
      adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor,&#xD;
      and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic&#xD;
      individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the&#xD;
      treatment of treatment of PA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Rationale:&#xD;
&#xD;
      Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and&#xD;
      adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by&#xD;
      smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented&#xD;
      patches, that typically occur on the upper part of the body, especially the face. A history&#xD;
      of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of&#xD;
      atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to&#xD;
      represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun&#xD;
      exposure is a triggering and accentuating factor.&#xD;
&#xD;
      PA is a common reason for dermatologic consultation due to its chronic course, frequent&#xD;
      relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years,&#xD;
      therefore impacting the quality of life. Emollients and mild-potency topical steroids are the&#xD;
      mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.&#xD;
&#xD;
      Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for&#xD;
      the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without&#xD;
      having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment,&#xD;
      another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy&#xD;
      of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study&#xD;
      evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our&#xD;
      knowledge there is no randomized placebo-controlled trial in the literature proving the&#xD;
      efficacy of pimecrolimus in PA.&#xD;
&#xD;
      Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA&#xD;
&#xD;
      Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis&#xD;
      alba.&#xD;
&#xD;
      Trial design: A randomized placebo-controlled double blinded trial establishing the&#xD;
      superiority of topical pimecrolimus 1% over placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>investigators and patients will be blinded to treatment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of repigmentation of index lesions</measure>
    <time_frame>9 weeks</time_frame>
    <description>Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pruritus and scaling</measure>
    <time_frame>3,6 and 9 weeks</time_frame>
    <description>IGA 4 point-scale (0: none - 3: severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's repigmentation change</measure>
    <time_frame>3,6 and 9 weeks</time_frame>
    <description>Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (&gt;75%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>9 weeks</time_frame>
    <description>(0: not satisfied, 1: satisfied, 2: very satisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>3,6 and 9 weeks</time_frame>
    <description>adverse events reporting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pityriasis Alba</condition>
  <arm_group>
    <arm_group_label>Pim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pl</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elidel (pimecrolimus 1%)</intervention_name>
    <description>topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed</description>
    <arm_group_label>Pim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cold Cream</intervention_name>
    <description>Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed</description>
    <arm_group_label>Pl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pityriasis alba Patients confirmed by a board certified dermatologist&#xD;
&#xD;
          -  Age over 2 years&#xD;
&#xD;
          -  Written informed consent signed by the patients or the legal guardians of patients&#xD;
             younger than 18 years in the native language (Arabic)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other concomitant dermatosis (except atopic dermatitis)&#xD;
&#xD;
          -  Use of topical steroids, or topical agents other than emollients and sunscreen, in the&#xD;
             last 4 weeks&#xD;
&#xD;
          -  Known allergy to pimecrolimus&#xD;
&#xD;
          -  Pregnant and nursing women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Josiane Helou, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Saint-Joseph University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>elio G kechichian, MD</last_name>
    <phone>+9613079072</phone>
    <email>elio.kechichian@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Saint Joseph University</name>
      <address>
        <city>Beirut</city>
        <zip>166830</zip>
        <country>Lebanon</country>
      </address>
    </facility>
    <contact>
      <last_name>elio kechichian</last_name>
      <phone>3079072</phone>
      <email>elio.kechichian@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St Joseph University, Beirut, Lebanon</investigator_affiliation>
    <investigator_full_name>elio kechichian</investigator_full_name>
    <investigator_title>Principal investigator, MD</investigator_title>
  </responsible_party>
  <keyword>pityriasis alba</keyword>
  <keyword>treatment</keyword>
  <keyword>topical calcineurin inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pityriasis</mesh_term>
    <mesh_term>Pityriasis Rosea</mesh_term>
    <mesh_term>Dandruff</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pimecrolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03834935
org study id: USJDERM1
nct id: NCT03834935
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and
      adolescents of darker phototypes. A history of atopic dermatitis is a well-known risk factor,
      and PA may be a minor manifestation of atopic dermatitis, although it can occur in nonatopic
      individuals as well. The objective is to evaluate the effect of topical pimecrolimus in the
      treatment of treatment of PA
Background and Rationale:

      Pityriasis alba (PA) is a common benign skin disorder, that usually affects children and
      adolescents of darker phototypes. PA usually manifests as erythematous lesions followed by
      smooth scales with residual characteristic pruritic or non-pruritic ill-defined hypopigmented
      patches, that typically occur on the upper part of the body, especially the face. A history
      of atopic dermatitis is a well-known risk factor, and PA may be a minor manifestation of
      atopic dermatitis, although it can occur in nonatopic individuals as well. It is thought to
      represent nonspecific dermatitis with residual post-inflammatory hypopigmentation. Sun
      exposure is a triggering and accentuating factor.

      PA is a common reason for dermatologic consultation due to its chronic course, frequent
      relapses and cosmetic appearance. Spontaneous healing occurs in several months to few years,
      therefore impacting the quality of life. Emollients and mild-potency topical steroids are the
      mainstay of treatment, with a potential risk of skin atrophy and hypopigmentation.

      Pimecrolimus is a topical calcineurin inhibitor that prevents T-cell activation, approved for
      the treatment of atopic dermatitis, and proved efficacious for seborrheic dermatitis, without
      having the potential adverse effects of topical corticosteroids. Tacrolimus 0.1% ointment,
      another calcineurin inhibitor is an effective and safe treatment for PA, a similar efficacy
      of calcitriol and tacrolimus was shown after 9 weeks of treatment. An exploratory study
      evaluated the efficacy of pimecrolimus cream in the treatment of PA. To the best of our
      knowledge there is no randomized placebo-controlled trial in the literature proving the
      efficacy of pimecrolimus in PA.

      Objective: To evaluate the effect of topical pimecrolimus in the treatment of treatment of PA

      Hypothesis: Pimecrolimus is an efficacious, well-tolerated and safe treatment for pityriasis
      alba.

      Trial design: A randomized placebo-controlled double blinded trial establishing the
      superiority of topical pimecrolimus 1% over placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: investigators and patients will be blinded to treatment
measure: Percentage of repigmentation of index lesions
time frame: 9 weeks
description: Objective percentage of repigmentation the index lesion (the largest lesion) by image analysis software (ImageJ software will be used to measure the lesion reduction area after treatments)
measure: Pruritus and scaling
time frame: 3,6 and 9 weeks
description: IGA 4 point-scale (0: none - 3: severe)
measure: Investigator's repigmentation change
time frame: 3,6 and 9 weeks
description: Clinical change is assessed by means of digital photographic registration (frontal, right, and left views). An independent observer clinically graded the global improvement as poor (0-25%), mild (26-50%), good (51-75%), and excellent (>75%).
measure: patient satisfaction
time frame: 9 weeks
description: (0: not satisfied, 1: satisfied, 2: very satisfied).
measure: Adverse events
time frame: 3,6 and 9 weeks
description: adverse events reporting
arm group label: Pim
arm group type: Experimental
description: 20 patients receiving topical Elidel (pimecrolimus 1%) bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
arm group label: Pl
arm group type: Placebo Comparator
description: 20 patients receiving placebo (control group), cold cream bid on the affected area for 9 weeks.Sunscreens will not be indicated, and hygienic habits will not be changed.
intervention type: Drug
intervention name: Elidel (pimecrolimus 1%)
description: topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
arm group label: Pim
intervention type: Drug
intervention name: Cold Cream
description: Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
arm group label: Pl
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Josiane Helou, MD
role: Study Chair
affiliation: Saint-Joseph University
last name: elio G kechichian, MD
phone: +9613079072
email: elio.kechichian@gmail.com
facility: 
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: St Joseph University, Beirut, Lebanon
investigator full name: elio kechichian
investigator title: Principal investigator, MD
mesh term: Pityriasis
mesh term: Pityriasis Rosea
mesh term: Dandruff
mesh term: Pimecrolimus
sharing ipd: Undecided