<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/NCT03807453</url>
  </required_header>
  <id_info>
    <org_study_id>IstanbulMU2</org_study_id>
    <nct_id>NCT03807453</nct_id>
  </id_info>
  <brief_title>Comparison of Scalp Microbiota of the Psoriasis and Seborrheic Dermatitis Patients</brief_title>
  <official_title>Comparison of Scalp Microbiota of the Patients With Psoriasis Vulgaris and Seborrheic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medeniyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turkish Dermatology Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Medeniyet 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>
      A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or&#xD;
      seborrheic dermatitis and the volunteer control group will be examined in our study. The&#xD;
      examples of the microbiota of the patients will be taken both the lesional scalp and the&#xD;
      lesion-free part of the scalp. Then, the microbiota differences between the lesioned scalp&#xD;
      and the lesion-free scalp of both groups, and the microbiome differences between the two&#xD;
      groups and the control group will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2019</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 18, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The scalp microbiota of the patients with psoriasis and seborrheic dermatitis</measure>
    <time_frame>6 months</time_frame>
    <description>The aim of this study is to compare the scalp microbiota of psoriasis vulgaris and seborrheic dermatitis both the lesion and lesion-free parts and also the control group and to assess their role on etiopathogenesis. Determining the microbiota of this region which is frequently involved and resistant to treatment may change the treatment approach. In addition, scalp microbiome of seborrheic dermatitis may be a causal factor of rapid relapse after treatment.&#xD;
The similarities between the microbiota of the psoriasis vulgaris and seborrheic dermatitis cases with only scalp involvement can guide us not only for the diagnosis but also the treatment. There are a few reports about the role of Malassezia subgroups in the pathogenesis, but it is known that there are many different flora members on the scalp. Exposing these can change both our diagnosis and treatment options.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The differences between the scalp microbiota of different countries</measure>
    <time_frame>6 months</time_frame>
    <description>Does the microbiota of the patients change between the countries? To our knowledge, there is no similar studies in present. Presenting the scalp microbiome of Turkish population can be a start to understand whether there is a difference in terms of the countries.</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Psoriasis Vulgaris</condition>
  <condition>Seborrheic Dermatitis</condition>
  <condition>Microbial Colonization</condition>
  <arm_group>
    <arm_group_label>Psoriasis Vulgaris patients-Lesion</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Psoriasis Vulgaris patients-Lesion free</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Seborrheic Dermatitis-Lesion</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Seborrheic Dermatitis-Lesion free</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Microbiota</intervention_name>
    <description>The scalp microbiota</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Psoriasis Vulgaris patients-Lesion</arm_group_label>
    <arm_group_label>Psoriasis Vulgaris patients-Lesion free</arm_group_label>
    <arm_group_label>Seborrheic Dermatitis-Lesion</arm_group_label>
    <arm_group_label>Seborrheic Dermatitis-Lesion free</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        primary care clinic and community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with scalp psoriasis&#xD;
&#xD;
          2. Patients with seborrheic dermatitis&#xD;
&#xD;
          3. Agree to participate in research 4 - Do not use any drugs for their disease topically&#xD;
             or systemically for two months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who do not want to participate in the study&#xD;
&#xD;
          2. Patients with psoriasis vulgaris or seborrheic dermatitis that does not effect scalp.&#xD;
&#xD;
          3. Those with chronic diseases that may affect skin microbiome&#xD;
&#xD;
          4. Patients using antibiotics, antifungal or antiviral therapy for any reason for the&#xD;
             last one month.&#xD;
&#xD;
          5. Patients who are using topical or systemic drugs for their illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Melek Aslan Kayıran</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Melek Aslan Kayıran</investigator_full_name>
    <investigator_title>Dermatologist, M.D.</investigator_title>
  </responsible_party>
  <keyword>Psoriasis Vulgaris</keyword>
  <keyword>Seborrheic Dermatitis</keyword>
  <keyword>Scalp</keyword>
  <keyword>Microbiome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Dermatitis, Seborrheic</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/NCT03807453
org study id: IstanbulMU2
nct id: NCT03807453
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
A sterile swap specimen taken from the scalp of the patients with psoriasis vulgaris or
      seborrheic dermatitis and the volunteer control group will be examined in our study. The
      examples of the microbiota of the patients will be taken both the lesional scalp and the
      lesion-free part of the scalp. Then, the microbiota differences between the lesioned scalp
      and the lesion-free scalp of both groups, and the microbiome differences between the two
      groups and the control group will be evaluated.
observational model: Case-Control
time perspective: Prospective
measure: The scalp microbiota of the patients with psoriasis and seborrheic dermatitis
time frame: 6 months
description: The aim of this study is to compare the scalp microbiota of psoriasis vulgaris and seborrheic dermatitis both the lesion and lesion-free parts and also the control group and to assess their role on etiopathogenesis. Determining the microbiota of this region which is frequently involved and resistant to treatment may change the treatment approach. In addition, scalp microbiome of seborrheic dermatitis may be a causal factor of rapid relapse after treatment.
The similarities between the microbiota of the psoriasis vulgaris and seborrheic dermatitis cases with only scalp involvement can guide us not only for the diagnosis but also the treatment. There are a few reports about the role of Malassezia subgroups in the pathogenesis, but it is known that there are many different flora members on the scalp. Exposing these can change both our diagnosis and treatment options.
measure: The differences between the scalp microbiota of different countries
time frame: 6 months
description: Does the microbiota of the patients change between the countries? To our knowledge, there is no similar studies in present. Presenting the scalp microbiome of Turkish population can be a start to understand whether there is a difference in terms of the countries.
arm group label: Psoriasis Vulgaris patients-Lesion
arm group label: Psoriasis Vulgaris patients-Lesion free
arm group label: Seborrheic Dermatitis-Lesion
arm group label: Seborrheic Dermatitis-Lesion free
arm group label: Control Group
intervention type: Other
intervention name: Microbiota
description: The scalp microbiota
arm group label: Control Group
arm group label: Psoriasis Vulgaris patients-Lesion
arm group label: Psoriasis Vulgaris patients-Lesion free
arm group label: Seborrheic Dermatitis-Lesion
arm group label: Seborrheic Dermatitis-Lesion free
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Melek Aslan Kayıran
investigator title: Dermatologist, M.D.
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Psoriasis
mesh term: Dermatitis
mesh term: Dermatitis, Seborrheic