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/NCT05989633</url>
    </required_header>
    <id_info>
      <org_study_id>Dercos DS in Dandruff</org_study_id>
      <nct_id>NCT05989633</nct_id>
    </id_info>
    <brief_title>DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022</brief_title>
    <official_title>DERCOS DS DANDRUFF TREATMENT OBSERVATIONAL STUDY 2022</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cosmetique Active International</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cosmetique Active International</source>
    <oversight_info>
      <has_dmc>No</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>
        The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 4, 2022</start_date>
    <completion_date type="Actual">June 29, 2023</completion_date>
    <primary_completion_date type="Actual">June 29, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Desquamation</measure>
      <time_frame>Baseline</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Desquamation</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Desquamation</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Irritation</measure>
      <time_frame>baseline</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Irritation</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Irritation</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema</measure>
      <time_frame>baseline</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Erythema</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale (0=absence to 4= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Itching</measure>
      <time_frame>baseline</time_frame>
      <description>Scale (0=absence to 10= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Itching</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale (0=absence to 10= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Itching</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale (0=absence to 10= very severe)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area involved</measure>
      <time_frame>baseline</time_frame>
      <description>scale from &lt;10% to &gt;90%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area involved</measure>
      <time_frame>Day 28</time_frame>
      <description>scale from &lt;10% to &gt;90%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area involved</measure>
      <time_frame>Day 56</time_frame>
      <description>scale from &lt;10% to &gt;90%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tolerance</measure>
      <time_frame>baseline</time_frame>
      <description>scale from 0= none to 5=very tolerated</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tolerance</measure>
      <time_frame>Day 28</time_frame>
      <description>scale from 0= none to 5=very tolerated</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement</measure>
      <time_frame>Day 28</time_frame>
      <description>scale from 0= worse to 5=very clearly improved</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Improvement</measure>
      <time_frame>Day 56</time_frame>
      <description>scale from 0= worse to 5=very clearly improved</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of dandruff on patient</measure>
      <time_frame>baseline</time_frame>
      <description>Scale from 0=not bothered at all to 5=very bothered</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of dandruff on patient</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale from 0=not bothered at all to 5=very bothered</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impact of dandruff on patient</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale from 0=not bothered at all to 5=very bothered</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global evaluation by investigator</measure>
      <time_frame>Day 28</time_frame>
      <description>Scale from 0=not at all satisfactory at all to 4=very satisfactory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global evaluation by investigator</measure>
      <time_frame>Day 56</time_frame>
      <description>Scale from 0=not at all satisfactory at all to 4=very satisfactory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of hair fiber and quality</measure>
      <time_frame>Day 56</time_frame>
      <description>scale from 0=worsened to 4=very improved</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Product respect/protects hair fiber</measure>
      <time_frame>Day 56</time_frame>
      <description>scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient product efficacy satisfaction</measure>
      <time_frame>Day 28</time_frame>
      <description>questionnare with scale ranging from 0=completely disagree to 5=completely agree</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient product efficacy satisfaction</measure>
      <time_frame>Day 56</time_frame>
      <description>questionnare with scale ranging from 0=completely disagree to 5=completely agree</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient product acceptability</measure>
      <time_frame>Day 28</time_frame>
      <description>scale ranging from 0=not satisfied at all to 10=very satisfied</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient product acceptability</measure>
      <time_frame>Day 56</time_frame>
      <description>scale ranging from 0=not satisfied at all to 10=very satisfied</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient global satisfaction</measure>
      <time_frame>Day 28</time_frame>
      <description>scale ranging from 0=not satisfied at all to 10=very satisfied</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient global satisfaction</measure>
      <time_frame>Day 56</time_frame>
      <description>scale ranging from 0=not satisfied at all to 10=very satisfied</description>
    </primary_outcome>
    <enrollment type="Actual">5131</enrollment>
    <condition>Dandruff</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)</intervention_name>
      <description>to assess the benefit of Dercos DS in subjects with dandruff</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects with dandruff or seborrheic dermatitis&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with dandruff or seborrheic dermatitis&#xD;
  &#xD;
            -  All hair types&#xD;
  &#xD;
            -  All ethnicities (Asian, Caucasian, Afro-American, African, Hispanic)&#xD;
  &#xD;
            -  Including patients with specific occlusion habits (for instance veil use at least 8&#xD;
               hours per day, hat use)&#xD;
  &#xD;
            -  Patients willing to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under 12 years old&#xD;
  &#xD;
            -  Pregnancy, breast feeding, childbearing potential without adequate contraception, or&#xD;
               irregular menstrual cycles.&#xD;
  &#xD;
            -  History of allergy, anaphylaxis or hypersensitivity to any of the ingredients of&#xD;
               Shampoo any of the ingredients of DERCOS ANTI-DANDRUFF normal to oily hair shampoo&#xD;
  &#xD;
            -  History of allergic contact dermatitis secondary to shampoo, conditioner, mask, and/or&#xD;
               leave-in.&#xD;
  &#xD;
            -  Has any clinical manifestations in the treatment(s) or other disorders that, in the&#xD;
               opinion of the investigator, may affect the evaluations or results of the study&#xD;
               products.- Inability to stay the study period (56 days +-5 days) without performing&#xD;
               any hair/scalp procedure, including coloring, straightening and cutting.&#xD;
  &#xD;
            -  Inability to attend all study visits and follow treatment regimen&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Marta Sar Pormian</name>
        <address>
          <city>Warsaw</city>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dandruff</keyword>
    <keyword>treatment satisfaction</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dandruff</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Selenium</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/NCT05989633
  org study id: Dercos DS in Dandruff
  nct id: NCT05989633
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the satisfaction / tolerance / cosmeticity of Dercos DS
  observational model: Cohort
  time perspective: Prospective
  measure: Desquamation
  time frame: Baseline
  description: Scale (0=absence to 4= very severe)
  measure: Desquamation
  time frame: Day 28
  description: Scale (0=absence to 4= very severe)
  measure: Desquamation
  time frame: Day 56
  description: Scale (0=absence to 4= very severe)
  measure: Irritation
  time frame: baseline
  description: Scale (0=absence to 4= very severe)
  measure: Irritation
  time frame: Day 28
  description: Scale (0=absence to 4= very severe)
  measure: Irritation
  time frame: Day 56
  description: Scale (0=absence to 4= very severe)
  measure: Erythema
  time frame: baseline
  description: Scale (0=absence to 4= very severe)
  measure: Erythema
  time frame: Day 28
  description: Scale (0=absence to 4= very severe)
  measure: Erythema
  time frame: Day 56
  description: Scale (0=absence to 4= very severe)
  measure: Itching
  time frame: baseline
  description: Scale (0=absence to 10= very severe)
  measure: Itching
  time frame: Day 28
  description: Scale (0=absence to 10= very severe)
  measure: Itching
  time frame: Day 56
  description: Scale (0=absence to 10= very severe)
  measure: Area involved
  time frame: baseline
  description: scale from <10% to >90%
  measure: Area involved
  time frame: Day 28
  description: scale from <10% to >90%
  measure: Area involved
  time frame: Day 56
  description: scale from <10% to >90%
  measure: Tolerance
  time frame: baseline
  description: scale from 0= none to 5=very tolerated
  measure: Tolerance
  time frame: Day 28
  description: scale from 0= none to 5=very tolerated
  measure: Improvement
  time frame: Day 28
  description: scale from 0= worse to 5=very clearly improved
  measure: Improvement
  time frame: Day 56
  description: scale from 0= worse to 5=very clearly improved
  measure: Impact of dandruff on patient
  time frame: baseline
  description: Scale from 0=not bothered at all to 5=very bothered
  measure: Impact of dandruff on patient
  time frame: Day 28
  description: Scale from 0=not bothered at all to 5=very bothered
  measure: Impact of dandruff on patient
  time frame: Day 56
  description: Scale from 0=not bothered at all to 5=very bothered
  measure: Global evaluation by investigator
  time frame: Day 28
  description: Scale from 0=not at all satisfactory at all to 4=very satisfactory
  measure: Global evaluation by investigator
  time frame: Day 56
  description: Scale from 0=not at all satisfactory at all to 4=very satisfactory
  measure: Assessment of hair fiber and quality
  time frame: Day 56
  description: scale from 0=worsened to 4=very improved
  measure: Product respect/protects hair fiber
  time frame: Day 56
  description: scale from 0=no, it is now more damaged/dry than before the treatment to 3=Yes, my hair fiber looks/feels better than before the treatment
  measure: Patient product efficacy satisfaction
  time frame: Day 28
  description: questionnare with scale ranging from 0=completely disagree to 5=completely agree
  measure: Patient product efficacy satisfaction
  time frame: Day 56
  description: questionnare with scale ranging from 0=completely disagree to 5=completely agree
  measure: Patient product acceptability
  time frame: Day 28
  description: scale ranging from 0=not satisfied at all to 10=very satisfied
  measure: Patient product acceptability
  time frame: Day 56
  description: scale ranging from 0=not satisfied at all to 10=very satisfied
  measure: Patient global satisfaction
  time frame: Day 28
  description: scale ranging from 0=not satisfied at all to 10=very satisfied
  measure: Patient global satisfaction
  time frame: Day 56
  description: scale ranging from 0=not satisfied at all to 10=very satisfied
  intervention type: Other
  intervention name: Dermocosmetic product: Selenium Disluphide Shampoo (Dercos DS)
  description: to assess the benefit of Dercos DS in subjects with dandruff
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Dandruff
  mesh term: Selenium
  sharing ipd: No