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/NCT05990309</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-11MS</org_study_id>
      <nct_id>NCT05990309</nct_id>
    </id_info>
    <brief_title>ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO</brief_title>
    <official_title>ASSESSMENT OF TRISTETRAPROLIN EXPRESSION IN LESIONAL SKIN OF PATIENTS WITH NON SEGMENTAL VITILIGO</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Vitiligo is characterized by the selective loss of melanocytes, which in turn leads to&#xD;
        totally amelanotic, non-scaly, chalky-white macule with distinct margins Vitiligo is the most&#xD;
        common depigmenting skin disorder, with an estimated prevalence of 0.5-2% of the population&#xD;
        in both adults and children worldwide Tumor necrosis factor (TNF-α), a pro-inflammatory&#xD;
        cytokine is necessary for Th1 mediated response and immune homeostasis and the up-regulation&#xD;
        of TNF-α can result in chronic inflammatory and autoimmune diseases . previous studies&#xD;
        revealed a rise in transcript and protein levels of TNF-α in vitiligo patients The prime&#xD;
        location of melanocytes, keratinocytes and fibroblasts is the epidermal microenvironment and&#xD;
        these cells are capable of TNF-α expression and secretion TNF-α acts as an autocrine as well&#xD;
        as a paracrine manner to suppress the melanocyte growth and proliferation ( Tristetraprolin&#xD;
        (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that&#xD;
        preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated&#xD;
        regions (3'UTR) of target genes . Additionally, Tristetraprolin functions by destabilizing&#xD;
        mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the&#xD;
        inflammatory processes, by favoring their degradation and/or preventing their efficient&#xD;
        translation The expression of proinflammatory mediator genes is tightly controlled by&#xD;
        post-transcriptional regulation, which is mediated by a set of immune-related RNA binding&#xD;
        proteins, such as tristetraprolin, Roquin, and Regnase&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>tristetraprolin</measure>
      <time_frame>12 months</time_frame>
      <description>Tristetraprolin (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated regions (3'UTR) of target genes (Brooks et al., 2013). Additionally, Tristetraprolin functions by destabilizing mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the inflammatory processes, by favoring their degradation and/or preventing their efficient translation</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Non-segmental Vitiligo</condition>
    <arm_group>
      <arm_group_label>non-segmental vitiligo</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>patients with non-segmental vitiligo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>skin biopsy</intervention_name>
      <description>skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>non-segmental vitiligo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  This study will include adult patients&gt;18 yrs with non -segmental vitiligo attending&#xD;
               the dermatology outpatient clinics at Sohag University, Egypt. A group of participants&#xD;
               will be included as a control group.This control group will be taken from patients&#xD;
               seeking for abdominoplasty in plastic surgery department at Sohag University Hospital.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1)Pregnancy. 2)Patients with chronic inflammatory skin disorders. 3)Patients on&#xD;
          antioxidants or anti-inflammatory drugs. 4)Patients on topical or systemic treatment for&#xD;
          vitiligo in the last 4 weeks prior to enrollment in the study.&#xD;
  &#xD;
          5)Patients with other autoimmune diseases as thyroiditis. lupus erythematosus and&#xD;
          rheumatoid arthritis 6)Patients with diabetes mellitus (DM).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>marwa k mahmoud, resident</last_name>
      <phone>01015429755</phone>
      <email>marwa_khaled_post@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>ramadan s abdou, professor</last_name>
    </overall_contact_backup>
    <reference>
      <citation>Alghamdi KM, Khurrum H, Taieb A, Ezzedine K. Treatment of generalized vitiligo with anti-TNF-alpha Agents. J Drugs Dermatol. 2012 Apr;11(4):534-9.</citation>
      <PMID>22453596</PMID>
    </reference>
    <reference>
      <citation>Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.</citation>
      <PMID>21839315</PMID>
    </reference>
    <reference>
      <citation>Alkhateeb A, Fain PR, Thody A, Bennett DC, Spritz RA. Epidemiology of vitiligo and associated autoimmune diseases in Caucasian probands and their families. Pigment Cell Res. 2003 Jun;16(3):208-14. doi: 10.1034/j.1600-0749.2003.00032.x.</citation>
      <PMID>12753387</PMID>
    </reference>
    <reference>
      <citation>Brooks SA, Blackshear PJ. Tristetraprolin (TTP): interactions with mRNA and proteins, and current thoughts on mechanisms of action. Biochim Biophys Acta. 2013 Jun-Jul;1829(6-7):666-79. doi: 10.1016/j.bbagrm.2013.02.003. Epub 2013 Feb 18.</citation>
      <PMID>23428348</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>marwa khaled mahmoud</investigator_full_name>
      <investigator_title>Resident AT DERMATOLOGY department-sohag hospital university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitiligo</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05990309
  org study id: Soh-Med-23-07-11MS
  nct id: NCT05990309
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Vitiligo is characterized by the selective loss of melanocytes, which in turn leads to
        totally amelanotic, non-scaly, chalky-white macule with distinct margins Vitiligo is the most
        common depigmenting skin disorder, with an estimated prevalence of 0.5-2% of the population
        in both adults and children worldwide Tumor necrosis factor (TNF-α), a pro-inflammatory
        cytokine is necessary for Th1 mediated response and immune homeostasis and the up-regulation
        of TNF-α can result in chronic inflammatory and autoimmune diseases . previous studies
        revealed a rise in transcript and protein levels of TNF-α in vitiligo patients The prime
        location of melanocytes, keratinocytes and fibroblasts is the epidermal microenvironment and
        these cells are capable of TNF-α expression and secretion TNF-α acts as an autocrine as well
        as a paracrine manner to suppress the melanocyte growth and proliferation ( Tristetraprolin
        (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that
        preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated
        regions (3'UTR) of target genes . Additionally, Tristetraprolin functions by destabilizing
        mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the
        inflammatory processes, by favoring their degradation and/or preventing their efficient
        translation The expression of proinflammatory mediator genes is tightly controlled by
        post-transcriptional regulation, which is mediated by a set of immune-related RNA binding
        proteins, such as tristetraprolin, Roquin, and Regnase
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: tristetraprolin
  time frame: 12 months
  description: Tristetraprolin (TTP) zinc finger protein 36 (ZFP36) is Ribonucleic acid (RNA) binding protein that preferentially binds to Adenylate-uridylate-rich (AU-rich) regions in the 3' untranslated regions (3'UTR) of target genes (Brooks et al., 2013). Additionally, Tristetraprolin functions by destabilizing mRNAs encoding for oncogenes, cytokines (as TNFα), and chemokines involved in the inflammatory processes, by favoring their degradation and/or preventing their efficient translation
  arm group label: non-segmental vitiligo
  arm group type: Active Comparator
  description: patients with non-segmental vitiligo
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Diagnostic Test
  intervention name: skin biopsy
  description: skin biopsy for immunohistochemical staining and assessment of tissue expression of tristetraprolin
  arm group label: control group
  arm group label: non-segmental vitiligo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: marwa k mahmoud, resident
  phone: 01015429755
  email: marwa_khaled_post@med.sohag.edu.eg
  last name: ramadan s abdou, professor
  citation: Alghamdi KM, Khurrum H, Taieb A, Ezzedine K. Treatment of generalized vitiligo with anti-TNF-alpha Agents. J Drugs Dermatol. 2012 Apr;11(4):534-9.
  PMID: 22453596
  citation: Alikhan A, Felsten LM, Daly M, Petronic-Rosic V. Vitiligo: a comprehensive overview Part I. Introduction, epidemiology, quality of life, diagnosis, differential diagnosis, associations, histopathology, etiology, and work-up. J Am Acad Dermatol. 2011 Sep;65(3):473-491. doi: 10.1016/j.jaad.2010.11.061.
  PMID: 21839315
  citation: Alkhateeb A, Fain PR, Thody A, Bennett DC, Spritz RA. Epidemiology of vitiligo and associated autoimmune diseases in Caucasian probands and their families. Pigment Cell Res. 2003 Jun;16(3):208-14. doi: 10.1034/j.1600-0749.2003.00032.x.
  PMID: 12753387
  citation: Brooks SA, Blackshear PJ. Tristetraprolin (TTP): interactions with mRNA and proteins, and current thoughts on mechanisms of action. Biochim Biophys Acta. 2013 Jun-Jul;1829(6-7):666-79. doi: 10.1016/j.bbagrm.2013.02.003. Epub 2013 Feb 18.
  PMID: 23428348
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: marwa khaled mahmoud
  investigator title: Resident AT DERMATOLOGY department-sohag hospital university
  mesh term: Vitiligo
  sharing ipd: Undecided