<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20240304061158N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-07</date_registration>
      <primary_sponsor>Behpad Teb Iranian</primary_sponsor>
      <public_title>Efficacy of BT DERMA  product in the treatment of cutaneous fungal infections</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Efficacy and Safety of Adding Topical BT DERMA to Standard Therapy versus Standard Therapy Alone in Patients with Dermatophytosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/89208</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: The study will be conducted using a split-body design.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Skin fungi (dermatophytes).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive BT DERMA  and clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed. Intervention 2: Control group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Ethical consideration about patient information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 1471, Immunoregulation Research Center, Research Centers of Shahed University, North Kargar Ave, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417953836</zip>
        <telephone>+98 21 6641 9712</telephone>
        <email>a.rashidi@shahed.ac.ir</email>
        <affiliation>Immunoregulation Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zohreh Khodashenas</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Station 32, Valiasr Street.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1418863981</zip>
        <telephone>+98 903 111 9779</telephone>
        <email>zohrehkhodashenas@ymail.com</email>
        <affiliation>Skin clinic of Dr. Khodashenas</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of dermatophytosis (fungal skin infection) by positive potassium hydroxide (KOH) test.
Subjects who have at least two lesions at two different anatomical locations
Provision of informed consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnant and lactating women
Patients with renal, hepatic, or heart failure
History of hypersensitivity to the study medications
Patients who have received systemic immunosuppressive drugs within two weeks prior to study entry
Patients with secondary bacterial infection
Patients taking medications that affect the absorption (e.g., antacids) or metabolism (e.g., anticonvulsants) of itraconazole</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dermatophytosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive BT DERMA  and clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.</i_keyword>
      <i_keyword>Control group: Patients will receive oral itraconazole 200 mg once daily plus ketoconazole 2% shampoo (with each bath, at least twice and up to five times weekly). For topical treatment, one lesion on one side of the limb will receive clotrimazole 1% cream twice daily for at least 4 weeks, continuing until improvement is observed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erythema. Timepoint: Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Pruritus. Timepoint: Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Scaling. Timepoint: Clinical evaluation was performed on days 0, 7, 14, 21, and 28 after study initiation. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>KOH test result. Timepoint: Days 0 and 28 after study initiation. Method of measurement: Performing KOH test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Safety. Timepoint: 7rd, 14th, 21th, 28nd days after starting the study. Method of measurement: Doctor examination and patient report.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahed university Immune Response Regulation Research Center</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Behpad Teb Iranian</source_name>
      <source_name>Shahed university Immune Response Regulation Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-12-08</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
