<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/NCT03252730</url>
  </required_header>
  <id_info>
    <org_study_id>LPT-15/2016</org_study_id>
    <nct_id>NCT03252730</nct_id>
  </id_info>
  <brief_title>In-Use Test With a Cosmetic Product</brief_title>
  <official_title>In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. August Wolff GmbH &amp; Co. KG Arzneimittel</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SIT Skin Investigation and Technology Hamburg GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr. August Wolff GmbH &amp; Co. KG Arzneimittel</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 the study is to evaluate the tolerance of the product WO 4260 by a dermatologist.&#xD;
      Additional objectives of this clinical in-use study are to evaluate the cosmetic features and&#xD;
      acceptance of the product by means of a questionnaire in an interview situation and by skin&#xD;
      hydration measurements on the scalp.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerance of the Test Product on the Scalp</measure>
    <time_frame>after 4 weeks of treatment</time_frame>
    <description>Change from Baseline Tolerance on the Scalp at 4 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin Hydration of the Scalp</measure>
    <time_frame>before product treatment; after 2 and 4 weeks of treatment</time_frame>
    <description>The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of the Test Product</measure>
    <time_frame>after 4 weeks of treatment</time_frame>
    <description>Subjective assessment of product performance in a questionnaire-based interview</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance of the Test Product on the Scalp</measure>
    <time_frame>after 2 weeks of treatment</time_frame>
    <description>Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Dermatitis, Atopic</condition>
  <arm_group>
    <arm_group_label>WO 4260 Cosmetic Product for Topical Use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WO 4260 is used to treat dry and itchy scalp</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WO 4260 Cosmetic Product for Topical Use</intervention_name>
    <description>Application on the hair scalp at least once a day over four weeks</description>
    <arm_group_label>WO 4260 Cosmetic Product for Topical Use</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: ≥ 18 years&#xD;
&#xD;
          -  sex: approx. 50% male and approx. 50% female&#xD;
&#xD;
          -  users of hair tonic for dry scalp&#xD;
&#xD;
          -  dry, itchy scalp prone to atopic eczema / atopic dermatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any deviation from the above-mentioned criteria&#xD;
&#xD;
          -  users of sour hair rinse&#xD;
&#xD;
          -  subjects who wash their hair more than once a day&#xD;
&#xD;
          -  other dermatological disorders (scars, moles) on the scalp&#xD;
&#xD;
          -  known incompatibilities to cosmetics and ingredients of cosmetic test products (please&#xD;
             see INCI)&#xD;
&#xD;
          -  topical medication in the test area within 1 month prior to study start&#xD;
&#xD;
          -  systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior&#xD;
             to starting of the study&#xD;
&#xD;
          -  systemic medication with retinoids, antihistamines and/or immunomodulators (e.g.&#xD;
             cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting&#xD;
             of the study&#xD;
&#xD;
          -  systemic illness of the subject at the beginning of the study&#xD;
&#xD;
          -  pregnancy and period of breastfeeding&#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_official>
    <last_name>Mona Mazinani, MD</last_name>
    <role>Study Director</role>
    <affiliation>SIT Skin Investigation and Technology Hamburg GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SIT Skin Investigation and Technology Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry scalp</keyword>
  <keyword>Itchy scalp</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03252730
org study id: LPT-15/2016
nct id: NCT03252730
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist.
      Additional objectives of this clinical in-use study are to evaluate the cosmetic features and
      acceptance of the product by means of a questionnaire in an interview situation and by skin
      hydration measurements on the scalp.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tolerance of the Test Product on the Scalp
time frame: after 4 weeks of treatment
description: Change from Baseline Tolerance on the Scalp at 4 weeks
measure: Skin Hydration of the Scalp
time frame: before product treatment; after 2 and 4 weeks of treatment
description: The measurement is performed using the DermaLab® device with the moisture pin (Cortex Technology)
measure: Performance of the Test Product
time frame: after 4 weeks of treatment
description: Subjective assessment of product performance in a questionnaire-based interview
measure: Tolerance of the Test Product on the Scalp
time frame: after 2 weeks of treatment
description: Dermatological assessment of the Scalp concerning the Tolerance of the Test Product regarding erythema, edema dryness etc. Each item is scored 0=absent to 4=extreme.
arm group label: WO 4260 Cosmetic Product for Topical Use
arm group type: Experimental
description: WO 4260 is used to treat dry and itchy scalp
intervention type: Other
intervention name: WO 4260 Cosmetic Product for Topical Use
description: Application on the hair scalp at least once a day over four weeks
arm group label: WO 4260 Cosmetic Product for Topical Use
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mona Mazinani, MD
role: Study Director
affiliation: SIT Skin Investigation and Technology Hamburg GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
sharing ipd: No