<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/NCT03823040</url>
  </required_header>
  <id_info>
    <org_study_id>OXIHebaSLNs</org_study_id>
    <nct_id>NCT03823040</nct_id>
  </id_info>
  <brief_title>Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel</brief_title>
  <official_title>Oxiconazole Nitrate Solid Lipid Nanoparticles : Formulation, In-vitro Characterization and Clinical Assessment of An Analogous Loaded Carbopol Gel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia 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>
      Clinical study for the developed oxiconazole nitrate solid lipid nanoparticles (SLNs) gel&#xD;
      system compared to the corresponding marketed product was conducted on 28 patients with&#xD;
      different types of tinea fungal infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical work has been carried out in accordance with The Code of Ethics of the World&#xD;
      Medical Association for experiments involving humans. The study was conducted on 28 patients&#xD;
      (12 to 50 years old) with tinea of different types attending the dermatology department&#xD;
      outpatient clinic of Minia University Hospital. Local institutional review board approval was&#xD;
      obtained for this study (ethical approval number is 23/12). Pregnant females and patients&#xD;
      with Immunocompromising disease,open wounds and psychological disorders were excluded.&#xD;
      Patients were subjected to skin irritation test by applying gel on an area of 2 square inch&#xD;
      to the back of hand. Then, examination for the presence of lesion or irritation was&#xD;
      conducted. The patients divided into two groups of 14 patients each. Tinox® group was male&#xD;
      patients from 12 to 43 years old. The included cases were 5 tinea pedis, 9 tinea versicolor.&#xD;
      Oxiconazole nitrate SLNs loaded gel group was 13 males and one female from17 to 50 years old.&#xD;
      The included cases were 3 tinea pedis, 8 tinea versicolor, 3 tinea circinate. An informed&#xD;
      consent has been obtained from all patients enrolled in the study for photography and&#xD;
      treatment. History, general local examination and laboratory investigation for all patients&#xD;
      were conducted.The patients were clinically examined after determining the type of infection.&#xD;
      Tinox® group was treated with Tinox® cream 1 % while oxiconazole nitrate SLNs loaded gel&#xD;
      group was treated with the oxiconazole nitrate SLNs-loaded gel. Treatment was performed by&#xD;
      rubbing the cream or gel twice daily for two/ four weeks according to different types of&#xD;
      tinea. Patients were advised to avoid sun exposure between 10 am and 4 pm and avoid removal&#xD;
      of the applied dose during the period of follow up, the clinical improvement of the patients&#xD;
      and length of treatment was assessed according to quartile grading scale patient&#xD;
      satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor&#xD;
      according to the following criteria. Excellent: both the patient and the physician agreed&#xD;
      that the result was satisfactory. Good: the result although acceptable was not quite up to&#xD;
      expectation of the patient, but the physicians were pleased with the outcome. Fair: the&#xD;
      improvement was evaluated by both the patient and the physician to be less than expected but&#xD;
      still with same improvement. Poor: unsatisfactory results to the patient and /or the&#xD;
      physician. All adverse effects were checked during study.High resolution digital photographs&#xD;
      were taken for lesions of all patients using identical camera folder setting before starting&#xD;
      and one-month post treatment. Clinical improvement was evaluated by physicians through&#xD;
      comparing photographs. The criteria for evaluations using a quartile grading scale was: 0=no&#xD;
      improvement. 1=mild (percent improvement, less than 25%), 2=moderate (percent improvement&#xD;
      25-49%), 3=good (percent improvement 50-74%), 4=excellent (percent improvement more than&#xD;
      75%). In addition, a patient satisfaction score was rated using the following scale, A. not&#xD;
      satisfied, B. somewhat satisfied, C. highly satisfied.&#xD;
&#xD;
      Skin scrapes were taken from each group before and after treatment. All skin scrapes were&#xD;
      routinely processed by potassium hydroxide 20% to be examined for presence of fungal&#xD;
      elements. A built-in camera and a light microscope were used to photograph and examine the&#xD;
      sectioned skin areas.&#xD;
&#xD;
      IBM SPSS® ( International business machine statistical Package for the Social Sciences&#xD;
      (version 22, USA) was utilised for data analysis. The acceptability of the tested&#xD;
      formulations was assessed using the chi-square test, P ≤ 0.05 was considered statistically&#xD;
      significant. All the results were presented as the mean ± standard deviation (SD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 23, 2018</primary_completion_date>
  <phase>Phase 1</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of clinical improvement using quartile grading scale patient satisfaction</measure>
    <time_frame>one month</time_frame>
    <description>the clinical improvement of the patients was assessed according to quartile grading scale patient satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor according to the following criteria. Excellent: both the patient and the physician agreed that the result was satisfactory. Good: the result although acceptable was not quite up to expectation of the patient, but the physicians were pleased with the outcome. Fair: the improvement was evaluated by both the patient and the physician to be less than expected but still with same improvement. Poor: unsatisfactory results to the patient and /or the physician. All adverse effects were checked during study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microscopical examination of skin scrapes for detection of fungal elements</measure>
    <time_frame>one month</time_frame>
    <description>Skin scrapes were taken from each group before and after treatment. All skin scrapes were routinely processed by potassium hydroxide 20% to be examined for presence of fungal elements. A built-in camera and a light microscope were used to photograph and examine the sectioned skin areas.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Tinea</condition>
  <arm_group>
    <arm_group_label>Tinox® group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Male patients (12 to 43 years old) including 5 cases tinea pedis, 9 tinea versicolor and treated with oxiconazole nitrate cream 1%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxiconazole nitrate SLNs loaded gel group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>13 males and one female (17 to 50 years old) including 3 cases tinea pedis, 8 tinea versicolor, 3 tinea circinate and treated with oxiconazole nitrate SLNs loaded gel</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxiconazole Nitrate Cream 1%</intervention_name>
    <description>Tinox® group was treated with oxiconazole nitrate cream 1 % . Treatment was performed by rubbing the cream twice daily for two/ four weeks according to different types of tinea.</description>
    <arm_group_label>Tinox® group</arm_group_label>
    <other_name>Tinox® cream 1 %</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxiconazole nitrate SLNs loaded gel.</intervention_name>
    <description>Oxiconazole nitrate SLNs loaded gel group was treated with oxiconazole nitrate SLNs loaded gel.Treatment was performed by rubbing the gel twice daily for two/ four weeks according to different types of tinea.</description>
    <arm_group_label>Oxiconazole nitrate SLNs loaded gel group</arm_group_label>
    <other_name>Developed SLNs gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with different types of tine infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females and patients with Immunocompromising disease, open wounds and&#xD;
             psychological disorders were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heba F Mansour, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Associate professor of Pharmaceutics, Faculty of Pharmacy, Minia and Deray University, Minia, Egypt.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minia University Hospital,dermatology department, out patient clinic</name>
      <address>
        <city>Minya</city>
        <zip>61519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minia University</investigator_affiliation>
    <investigator_full_name>Heba Mansour</investigator_full_name>
    <investigator_title>Assistant professor of pharmaceutics, Faculty of Pharmacy, Minia University</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxiconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03823040
org study id: OXIHebaSLNs
nct id: NCT03823040
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical study for the developed oxiconazole nitrate solid lipid nanoparticles (SLNs) gel
      system compared to the corresponding marketed product was conducted on 28 patients with
      different types of tinea fungal infection.
The clinical work has been carried out in accordance with The Code of Ethics of the World
      Medical Association for experiments involving humans. The study was conducted on 28 patients
      (12 to 50 years old) with tinea of different types attending the dermatology department
      outpatient clinic of Minia University Hospital. Local institutional review board approval was
      obtained for this study (ethical approval number is 23/12). Pregnant females and patients
      with Immunocompromising disease,open wounds and psychological disorders were excluded.
      Patients were subjected to skin irritation test by applying gel on an area of 2 square inch
      to the back of hand. Then, examination for the presence of lesion or irritation was
      conducted. The patients divided into two groups of 14 patients each. Tinox® group was male
      patients from 12 to 43 years old. The included cases were 5 tinea pedis, 9 tinea versicolor.
      Oxiconazole nitrate SLNs loaded gel group was 13 males and one female from17 to 50 years old.
      The included cases were 3 tinea pedis, 8 tinea versicolor, 3 tinea circinate. An informed
      consent has been obtained from all patients enrolled in the study for photography and
      treatment. History, general local examination and laboratory investigation for all patients
      were conducted.The patients were clinically examined after determining the type of infection.
      Tinox® group was treated with Tinox® cream 1 % while oxiconazole nitrate SLNs loaded gel
      group was treated with the oxiconazole nitrate SLNs-loaded gel. Treatment was performed by
      rubbing the cream or gel twice daily for two/ four weeks according to different types of
      tinea. Patients were advised to avoid sun exposure between 10 am and 4 pm and avoid removal
      of the applied dose during the period of follow up, the clinical improvement of the patients
      and length of treatment was assessed according to quartile grading scale patient
      satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor
      according to the following criteria. Excellent: both the patient and the physician agreed
      that the result was satisfactory. Good: the result although acceptable was not quite up to
      expectation of the patient, but the physicians were pleased with the outcome. Fair: the
      improvement was evaluated by both the patient and the physician to be less than expected but
      still with same improvement. Poor: unsatisfactory results to the patient and /or the
      physician. All adverse effects were checked during study.High resolution digital photographs
      were taken for lesions of all patients using identical camera folder setting before starting
      and one-month post treatment. Clinical improvement was evaluated by physicians through
      comparing photographs. The criteria for evaluations using a quartile grading scale was: 0=no
      improvement. 1=mild (percent improvement, less than 25%), 2=moderate (percent improvement
      25-49%), 3=good (percent improvement 50-74%), 4=excellent (percent improvement more than
      75%). In addition, a patient satisfaction score was rated using the following scale, A. not
      satisfied, B. somewhat satisfied, C. highly satisfied.

      Skin scrapes were taken from each group before and after treatment. All skin scrapes were
      routinely processed by potassium hydroxide 20% to be examined for presence of fungal
      elements. A built-in camera and a light microscope were used to photograph and examine the
      sectioned skin areas.

      IBM SPSS® ( International business machine statistical Package for the Social Sciences
      (version 22, USA) was utilised for data analysis. The acceptability of the tested
      formulations was assessed using the chi-square test, P ≤ 0.05 was considered statistically
      significant. All the results were presented as the mean ± standard deviation (SD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Measurement of clinical improvement using quartile grading scale patient satisfaction
time frame: one month
description: the clinical improvement of the patients was assessed according to quartile grading scale patient satisfaction. It was rated by the patient and the physician as excellent, good, fair and poor according to the following criteria. Excellent: both the patient and the physician agreed that the result was satisfactory. Good: the result although acceptable was not quite up to expectation of the patient, but the physicians were pleased with the outcome. Fair: the improvement was evaluated by both the patient and the physician to be less than expected but still with same improvement. Poor: unsatisfactory results to the patient and /or the physician. All adverse effects were checked during study.
measure: Microscopical examination of skin scrapes for detection of fungal elements
time frame: one month
description: Skin scrapes were taken from each group before and after treatment. All skin scrapes were routinely processed by potassium hydroxide 20% to be examined for presence of fungal elements. A built-in camera and a light microscope were used to photograph and examine the sectioned skin areas.
arm group label: Tinox® group
arm group type: Active Comparator
description: Male patients (12 to 43 years old) including 5 cases tinea pedis, 9 tinea versicolor and treated with oxiconazole nitrate cream 1%.
arm group label: Oxiconazole nitrate SLNs loaded gel group
arm group type: Experimental
description: 13 males and one female (17 to 50 years old) including 3 cases tinea pedis, 8 tinea versicolor, 3 tinea circinate and treated with oxiconazole nitrate SLNs loaded gel
intervention type: Drug
intervention name: Oxiconazole Nitrate Cream 1%
description: Tinox® group was treated with oxiconazole nitrate cream 1 % . Treatment was performed by rubbing the cream twice daily for two/ four weeks according to different types of tinea.
arm group label: Tinox® group
other name: Tinox® cream 1 %
intervention type: Drug
intervention name: Oxiconazole nitrate SLNs loaded gel.
description: Oxiconazole nitrate SLNs loaded gel group was treated with oxiconazole nitrate SLNs loaded gel.Treatment was performed by rubbing the gel twice daily for two/ four weeks according to different types of tinea.
arm group label: Oxiconazole nitrate SLNs loaded gel group
other name: Developed SLNs gel
criteria: 
gender: All
minimum age: 12 Years
maximum age: 50 Years
healthy volunteers: No
last name: Heba F Mansour, Ph.D
role: Study Director
affiliation: Associate professor of Pharmaceutics, Faculty of Pharmacy, Minia and Deray University, Minia, Egypt.
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Minia University
investigator full name: Heba Mansour
investigator title: Assistant professor of pharmaceutics, Faculty of Pharmacy, Minia University
mesh term: Oxiconazole
sharing ipd: Undecided