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/NCT06000189</url>
    </required_header>
    <id_info>
      <org_study_id>2022/0340</org_study_id>
      <nct_id>NCT06000189</nct_id>
    </id_info>
    <brief_title>Phototherapy: Not a Cause of Demodicosis</brief_title>
    <official_title>The Effect of Phototherapy on Demodex Density: A Case-Control Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Medeniyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        The purpose of this study is to determine whether there is an increase in the frequency of&#xD;
        demodicosis and the density of Demodex mites after 20 sessions of phototherapy.&#xD;
  &#xD;
        The main question(s)it aims to answer are;&#xD;
  &#xD;
          -  Are Demodex mites higher in patients treated with phototherapy?&#xD;
  &#xD;
          -  In which localization and with what intensity was demodicosis most common? Participants&#xD;
             will be assessed using standardized skin surface biopsy technique in four localization&#xD;
             on their face.&#xD;
  &#xD;
        Researchers will compare demodex intensity per cm² to see if the phototherapy effects demodex&#xD;
        intensity on patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study employee as a case-control study to compare the Demodex densities before and after&#xD;
        20 sessions of narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy in&#xD;
        patients who will receive phototherapy for any dermatological indication. The study is going&#xD;
        to be conducted at Istanbul Medeniyet University Department of Dermatology between June 2023&#xD;
        and August 2023. Ethical approval was obtained from Istanbul Medeniyet University Local&#xD;
        Ethics Committee (decision number: 2022/0340).&#xD;
  &#xD;
        Demographic and medical information, including age, gender, smoking and alcohol habits,&#xD;
        dermatological indication of phototherapy, presence of facial involvement of the relevant&#xD;
        disease, and use of medications or cosmetic products on the face in the last week, will be&#xD;
        obtained through a standardized form. Patients will be evaluated by the researcher for the&#xD;
        presence of clinical conditions associated with primary/secondary demodicosis, such as acne,&#xD;
        rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis&#xD;
        folliculorum.&#xD;
  &#xD;
        The standardized skin surface biopsy (SSSB) technique is going to be utilized to assess&#xD;
        Demodex density. Skin samples will be obtained from four regions of the participants' faces,&#xD;
        including the forehead, right cheek, left cheek, and the nose, before phototherapy and after&#xD;
        20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be&#xD;
        drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed&#xD;
        with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of&#xD;
        cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the&#xD;
        adhesive surface of the slide will be pressed onto the skin surface for approximately one&#xD;
        minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined&#xD;
        under a light microscope at x10 and x40 magnifications after applying immersion oil. The&#xD;
        presence of more than five Demodex mites per square centimeter will be defined as increased&#xD;
        Demodex density.&#xD;
  &#xD;
        Statistical analysis will be performed using IBM Statistical Package for the Social Sciences&#xD;
        [SPSS] v.17. Means, standard deviations, or frequencies will be calculated for relevant&#xD;
        variables as required. Paired samples t-test will be used to compare Demodex densities, and&#xD;
        the McNemar test will be used to compare the presence of demodicosis between pre- and&#xD;
        post-treatment. A p-value of less than 0.05 will be considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Phototherapy: Not a Cause of Demodicosis</measure>
      <time_frame>4 months</time_frame>
      <description>A standardized form is going to be used to collect demographic information, and details regarding smoking and alcohol habits. Additional information regarding their treatment regimens will be recorded. Furthermore patients will be evaluated for the presence of acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folicullorum, as these conditions have been associated with an increased demodicosis. After that the standardized skin surface biopsy (SSSB) technique will be performed before and after phototherapy to assess Demodex density.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Demodicidosis</condition>
    <arm_group>
      <arm_group_label>Participants who received phototherapy for various dermatological indications</arm_group_label>
      <description>A case-control study will be conducted participants who received narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy for various dermatological indications. Standardized skin surface biopsies (SSSB) were performed before and after phototherapy to assess Demodex density. Demographic data, medical information, and the presence of demodex-related skin conditions were recorded using a standardized form. Statistical analysis will be performed to compare the demodex densities and prevalence of demodicosis between baseline and 20th session of phototherapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Standardized skin surface biopsies (SSSB)</intervention_name>
      <description>Skin samples will be obtained from four regions of the participants' faces, including the forehead, right cheek, left cheek, and the nose, before phototherapy and after 20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the adhesive surface of the slide will be pressed onto the skin surface for approximately one minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined under a light microscope at x10 and x40 magnifications after applying immersion oil. The presence of more than five Demodex mites per square centimeter will be defined as increased Demodex density.</description>
      <arm_group_label>Participants who received phototherapy for various dermatological indications</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants aged between 18 and 65 which are received narrow-band ultraviolet B (NBUVB) or&#xD;
          ultraviolet A-1 (UVA-1) therapy for various dermatological indications&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who received phototherapy for various dermatological indications&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Melek Aslan Kayıran, Ass.Prof</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul Medeniyet University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>sümeyye Altıntaş Kakşi, Specialist</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul Medeniyet University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Vefa Aslı Erdemir, Prof</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul Medeniyet University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yeşim Dede, Resident</last_name>
      <role>Study Chair</role>
      <affiliation>Istanbul Medeniyet University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medeniyet University</name>
        <address>
          <city>Istanbul</city>
          <state>Kadıköy</state>
          <zip>34720</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Turkmen D, Turkoglu G. Demodex Infestation in Patients with Rosacea. Turkiye Parazitol Derg. 2019 Dec 23;43(4):194-197. doi: 10.4274/tpd.galenos.2019.6456.</citation>
      <PMID>31865655</PMID>
    </results_reference>
    <results_reference>
      <citation>Kulac M, Ciftci IH, Karaca S, Cetinkaya Z. Clinical importance of Demodex folliculorum in patients receiving phototherapy. Int J Dermatol. 2008 Jan;47(1):72-7. doi: 10.1111/j.1365-4632.2007.03336.x.</citation>
      <PMID>18173609</PMID>
    </results_reference>
    <results_reference>
      <citation>Forton F, Seys B. Density of Demodex folliculorum in rosacea: a case-control study using standardized skin-surface biopsy. Br J Dermatol. 1993 Jun;128(6):650-9. doi: 10.1111/j.1365-2133.1993.tb00261.x.</citation>
      <PMID>8338749</PMID>
    </results_reference>
    <results_reference>
      <citation>Aytekin S. Outbreak of demodex folliculitis on the face and upper trunk during 311-nm UVB therapy for psoriasis. J Eur Acad Dermatol Venereol. 2004 Mar;18(2):236-8. doi: 10.1111/j.1468-3083.2004.00898.x. No abstract available.</citation>
      <PMID>15009323</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
      <investigator_full_name>Hasan Aksoy</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>Demodex, phototherapy, NBUVB, demodicosis, immunsupression</keyword>
    <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/NCT06000189
  org study id: 2022/0340
  nct id: NCT06000189
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine whether there is an increase in the frequency of
        demodicosis and the density of Demodex mites after 20 sessions of phototherapy.
  
        The main question(s)it aims to answer are;
  
          -  Are Demodex mites higher in patients treated with phototherapy?
  
          -  In which localization and with what intensity was demodicosis most common? Participants
             will be assessed using standardized skin surface biopsy technique in four localization
             on their face.
  
        Researchers will compare demodex intensity per cm² to see if the phototherapy effects demodex
        intensity on patients.
  This study employee as a case-control study to compare the Demodex densities before and after
        20 sessions of narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy in
        patients who will receive phototherapy for any dermatological indication. The study is going
        to be conducted at Istanbul Medeniyet University Department of Dermatology between June 2023
        and August 2023. Ethical approval was obtained from Istanbul Medeniyet University Local
        Ethics Committee (decision number: 2022/0340).
  
        Demographic and medical information, including age, gender, smoking and alcohol habits,
        dermatological indication of phototherapy, presence of facial involvement of the relevant
        disease, and use of medications or cosmetic products on the face in the last week, will be
        obtained through a standardized form. Patients will be evaluated by the researcher for the
        presence of clinical conditions associated with primary/secondary demodicosis, such as acne,
        rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis
        folliculorum.
  
        The standardized skin surface biopsy (SSSB) technique is going to be utilized to assess
        Demodex density. Skin samples will be obtained from four regions of the participants' faces,
        including the forehead, right cheek, left cheek, and the nose, before phototherapy and after
        20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be
        drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed
        with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of
        cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the
        adhesive surface of the slide will be pressed onto the skin surface for approximately one
        minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined
        under a light microscope at x10 and x40 magnifications after applying immersion oil. The
        presence of more than five Demodex mites per square centimeter will be defined as increased
        Demodex density.
  
        Statistical analysis will be performed using IBM Statistical Package for the Social Sciences
        [SPSS] v.17. Means, standard deviations, or frequencies will be calculated for relevant
        variables as required. Paired samples t-test will be used to compare Demodex densities, and
        the McNemar test will be used to compare the presence of demodicosis between pre- and
        post-treatment. A p-value of less than 0.05 will be considered statistically significant.
  observational model: Case-Control
  time perspective: Prospective
  measure: Phototherapy: Not a Cause of Demodicosis
  time frame: 4 months
  description: A standardized form is going to be used to collect demographic information, and details regarding smoking and alcohol habits. Additional information regarding their treatment regimens will be recorded. Furthermore patients will be evaluated for the presence of acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folicullorum, as these conditions have been associated with an increased demodicosis. After that the standardized skin surface biopsy (SSSB) technique will be performed before and after phototherapy to assess Demodex density.
  arm group label: Participants who received phototherapy for various dermatological indications
  description: A case-control study will be conducted participants who received narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy for various dermatological indications. Standardized skin surface biopsies (SSSB) were performed before and after phototherapy to assess Demodex density. Demographic data, medical information, and the presence of demodex-related skin conditions were recorded using a standardized form. Statistical analysis will be performed to compare the demodex densities and prevalence of demodicosis between baseline and 20th session of phototherapy.
  intervention type: Procedure
  intervention name: Standardized skin surface biopsies (SSSB)
  description: Skin samples will be obtained from four regions of the participants' faces, including the forehead, right cheek, left cheek, and the nose, before phototherapy and after 20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the adhesive surface of the slide will be pressed onto the skin surface for approximately one minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined under a light microscope at x10 and x40 magnifications after applying immersion oil. The presence of more than five Demodex mites per square centimeter will be defined as increased Demodex density.
  arm group label: Participants who received phototherapy for various dermatological indications
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  last name: Melek Aslan Kayıran, Ass.Prof
  role: Study Chair
  affiliation: Istanbul Medeniyet University
  last name: sümeyye Altıntaş Kakşi, Specialist
  role: Study Chair
  affiliation: Istanbul Medeniyet University
  last name: Vefa Aslı Erdemir, Prof
  role: Study Chair
  affiliation: Istanbul Medeniyet University
  last name: Yeşim Dede, Resident
  role: Study Chair
  affiliation: Istanbul Medeniyet University
  facility: 
  country: Turkey
  citation: Turkmen D, Turkoglu G. Demodex Infestation in Patients with Rosacea. Turkiye Parazitol Derg. 2019 Dec 23;43(4):194-197. doi: 10.4274/tpd.galenos.2019.6456.
  PMID: 31865655
  citation: Kulac M, Ciftci IH, Karaca S, Cetinkaya Z. Clinical importance of Demodex folliculorum in patients receiving phototherapy. Int J Dermatol. 2008 Jan;47(1):72-7. doi: 10.1111/j.1365-4632.2007.03336.x.
  PMID: 18173609
  citation: Forton F, Seys B. Density of Demodex folliculorum in rosacea: a case-control study using standardized skin-surface biopsy. Br J Dermatol. 1993 Jun;128(6):650-9. doi: 10.1111/j.1365-2133.1993.tb00261.x.
  PMID: 8338749
  citation: Aytekin S. Outbreak of demodex folliculitis on the face and upper trunk during 311-nm UVB therapy for psoriasis. J Eur Acad Dermatol Venereol. 2004 Mar;18(2):236-8. doi: 10.1111/j.1468-3083.2004.00898.x. No abstract available.
  PMID: 15009323
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medeniyet University
  investigator full name: Hasan Aksoy
  investigator title: Medical Doctor
  sharing ipd: Undecided