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/NCT05999474</url>
    </required_header>
    <id_info>
      <org_study_id>Kasr Alainy</org_study_id>
      <nct_id>NCT05999474</nct_id>
    </id_info>
    <brief_title>Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial</brief_title>
    <official_title>Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined&#xD;
        with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <phase>Phase 4</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>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>treatment of onychomycosis</measure>
      <time_frame>6 months</time_frame>
      <description>Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Onychomycosis of Fingernail</condition>
    <arm_group>
      <arm_group_label>Fractional CO2 laser combined with topical tioconazole</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fractional CO2 laser (10,600 nm) will be done. The sessions will be done every 2 weeks.&#xD;
  Topical tioconazole 28% nail solution will be applied in between the sessions twice daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Q switched ND-Yag</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Laser protocol with a specific parameters will be applied on the affected nails. In one session two passes across each nail plate will be performed with two minutes pauses between each pass. Sessions will be done every 2 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topical tioconazole</intervention_name>
      <description>Laser</description>
      <arm_group_label>Fractional CO2 laser combined with topical tioconazole</arm_group_label>
      <arm_group_label>Q switched ND-Yag</arm_group_label>
      <other_name>Laser</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Age group &gt;18 years.&#xD;
  &#xD;
                 -  Patients of both genders.&#xD;
  &#xD;
                 -  Patients with OM any type.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Pregnancy&#xD;
  &#xD;
                 -  Localized bacterial infection around the affected nail&#xD;
  &#xD;
                 -  Concomitant nails disease that causes nail dystrophy or discoloration such as&#xD;
                    psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis&#xD;
                    and treatment&#xD;
  &#xD;
                 -  Hypersensitivity to terbinafine&#xD;
  &#xD;
                 -  Intake of oral antifungal medication within the last 3 months or used topical&#xD;
                    antifungal medication within the last 2 weeks prior to the laser treatment&#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>Amira Elbendary, MD</last_name>
      <phone>01555668584</phone>
      <email>aelbendary@kasralainy.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Khadiga Sayed, MD</last_name>
      <phone>+201060105697</phone>
      <phone_ext>+201060105697</phone_ext>
      <email>Diga1980@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kasr Alainy Faculty of Medicine</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amira Elbendary, MD</last_name>
        <phone>01555668584</phone>
        <email>aelbendary@kasralainy.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 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>Cairo University</investigator_affiliation>
      <investigator_full_name>Amira Elbendary</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Onychomycosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tioconazole</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05999474
  org study id: Kasr Alainy
  nct id: NCT05999474
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined
        with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: treatment of onychomycosis
  time frame: 6 months
  description: Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement
  arm group label: Fractional CO2 laser combined with topical tioconazole
  arm group type: Experimental
  description: Fractional CO2 laser (10,600 nm) will be done. The sessions will be done every 2 weeks.
  Topical tioconazole 28% nail solution will be applied in between the sessions twice daily
  arm group label: Q switched ND-Yag
  arm group type: Active Comparator
  description: Laser protocol with a specific parameters will be applied on the affected nails. In one session two passes across each nail plate will be performed with two minutes pauses between each pass. Sessions will be done every 2 weeks
  intervention type: Drug
  intervention name: Topical tioconazole
  description: Laser
  arm group label: Fractional CO2 laser combined with topical tioconazole
  arm group label: Q switched ND-Yag
  other name: Laser
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Amira Elbendary, MD
  phone: 01555668584
  email: aelbendary@kasralainy.edu.eg
  last name: Khadiga Sayed, MD
  phone: +201060105697
  phone ext: +201060105697
  email: Diga1980@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Amira Elbendary
  investigator title: Lecturer
  mesh term: Onychomycosis
  mesh term: Tioconazole
  sharing ipd: No