<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/NCT03007615</url>
  </required_header>
  <id_info>
    <org_study_id>Kley Hertz 007</org_study_id>
    <nct_id>NCT03007615</nct_id>
  </id_info>
  <brief_title>Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.</brief_title>
  <acronym>DERM GYN ACCEP</acronym>
  <official_title>Dermal and Gynecological Acceptability (Irritability and Sensitization in the Genital Mucosa) of an Investigational Product and Evaluation of Moisture Efficacy by TEWL and Perceived Efficacy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kley Hertz S/A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kley Hertz S/A</source>
  <brief_summary>
    <textblock>
      To evaluate the safety of an investigational product through the verification of signs of&#xD;
      irritability and sensitization of the genital mucosa, as well as the instrumental&#xD;
      moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy&#xD;
      perceived by the volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">February 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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the product's efficiency as a moisturizer through subjective evaluation</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Female Dry Genital Mucosa</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intimate Lubricant Gel</intervention_name>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female sex with active sex life;&#xD;
&#xD;
          -  Age group: between 45 and 65 years old;&#xD;
&#xD;
          -  Menopause for at least six months;&#xD;
&#xD;
          -  Whole skin in the region of product analysis;&#xD;
&#xD;
          -  No history of reaction to products of the same category&#xD;
&#xD;
          -  Understanding, agreement and signature of the Term of Free and Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gestation or risk of gestation;&#xD;
&#xD;
          -  Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the&#xD;
             study);&#xD;
&#xD;
          -  Active cutaneous pathologies (local and / or disseminated) in the evaluation area;&#xD;
&#xD;
          -  Pathologies that cause suppression of immunity, such as diabetes, HIV, etc.;&#xD;
&#xD;
          -  Endocrine pathologies such as thyroid disorders, ovarian or adrenal gland disorders;&#xD;
&#xD;
          -  Any infection in the region of analysis of the product diagnosed at the time of&#xD;
             inclusion;&#xD;
&#xD;
          -  Other conditions considered by the investigating physician as reasonable for&#xD;
             disqualification of the individual from the study participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03007615
org study id: Kley Hertz 007
nct id: NCT03007615
lead sponsor: 
To evaluate the safety of an investigational product through the verification of signs of
      irritability and sensitization of the genital mucosa, as well as the instrumental
      moisturizing efficacy by TEWL and barrier integrity analysis, in addition to the efficacy
      perceived by the volunteers.
allocation: N/A
intervention model: Single Group Assignment
masking: Single (Participant)
measure: Evaluation of the product's efficiency as a moisturizer through subjective evaluation
time frame: 30 days
arm group label: Experimental group
arm group type: Experimental
intervention type: Other
intervention name: Intimate Lubricant Gel
arm group label: Experimental group
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor