<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/NCT03762551</url>
  </required_header>
  <id_info>
    <org_study_id>Dermatology 11</org_study_id>
    <nct_id>NCT03762551</nct_id>
  </id_info>
  <brief_title>Janus Kinase 1 in Vitiligo &amp; Psoriasis</brief_title>
  <official_title>Expression of Janus Kinase 1 in Vitiligo and Psoriasis Before and After Narrow Band UVB: a Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Assessment of the level of JAK1 in both vitiligo and psoriasis patients before and after&#xD;
      treatment with NB-UVB which is considered a gold standard therapy for both diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Vitiligo</condition>
  <arm_group>
    <arm_group_label>vitiligo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>psoriasis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>assess the level of JAK1 in controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>skin biopsy</intervention_name>
    <description>Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site). One skin biopsy was taken from the skin of each of the 10 control healthy participants. Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.</description>
    <arm_group_label>controls</arm_group_label>
    <arm_group_label>psoriasis</arm_group_label>
    <arm_group_label>vitiligo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age above 12 years of age.&#xD;
&#xD;
          -  psoriasis vulgaris or non-segmental vitiligo&#xD;
&#xD;
          -  patients who received no systemic or topical treatment at least 6 weeks prior to&#xD;
             enrollment into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psoriasis patients with erythrodermic psoriasis, pustular psoriasis or associated&#xD;
             psoriatic arthritis&#xD;
&#xD;
          -  vitiligo patients with segmental or universal vitiligo were excluded from the study.&#xD;
&#xD;
          -  any patient with a photosensitive disorder or any contraindication to phototherapy&#xD;
             exposure, e.g., history or presence of malignant or premalignant skin lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Maha Fathy Elmasry</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Vitiligo</mesh_term>
  </condition_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/NCT03762551
org study id: Dermatology 11
nct id: NCT03762551
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Assessment of the level of JAK1 in both vitiligo and psoriasis patients before and after
      treatment with NB-UVB which is considered a gold standard therapy for both diseases.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measurement of the tissue level of JAK1 in both vitiligo and psoriasis patients before and after treatment with NB-UVB
time frame: 1 year
arm group label: vitiligo
arm group type: Experimental
description: assess the level of JAK1 in vitiligo patients before and after treatment with NB-UVB
arm group label: psoriasis
arm group type: Active Comparator
description: assess the level of JAK1 in psoriasis patients before and after treatment with NB-UVB
arm group label: controls
arm group type: Other
description: assess the level of JAK1 in controls
intervention type: Other
intervention name: skin biopsy
description: Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site). One skin biopsy was taken from the skin of each of the 10 control healthy participants. Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.
arm group label: controls
arm group label: psoriasis
arm group label: vitiligo
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Maha Fathy Elmasry
investigator title: principal investigator
mesh term: Psoriasis
mesh term: Vitiligo