<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/NCT02191813</url>
  </required_header>
  <id_info>
    <org_study_id>1135.3</org_study_id>
    <nct_id>NCT02191813</nct_id>
  </id_info>
  <brief_title>Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers</brief_title>
  <official_title>The Ability of Seresis to Act as a Skin Protection Agent: a Double-blind, Parallel Group, Placebo-controlled Trial in Healthy, Young Female Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by&#xD;
      Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression)&#xD;
      activated by UV radiation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2000</start_date>
  <primary_completion_date type="Actual">July 2000</primary_completion_date>
  <phase>Phase 2</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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples</measure>
    <time_frame>Day 84</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples</measure>
    <time_frame>Day 84</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in MMP-1 levels measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MMP-9 levels measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in MMP-3 levels measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pro-MMPs levels measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tissue inhibitor (TIMP-1) levels measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heme oxygenase-1 level measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Density of Langerhans cells measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell proliferation and differentiation measured in skin samples</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of vitamin E</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of beta-carotene</measure>
    <time_frame>up to day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 112 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal changes in laboratory parameters</measure>
    <time_frame>up to day 98</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by volunteer on a 4-point scale</measure>
    <time_frame>Day 84</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recall antigene (skin immune status) measured in the skin sample</measure>
    <time_frame>up to 84 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of light sensitivity</measure>
    <time_frame>up to 84 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Seresis®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seresis®</intervention_name>
    <arm_group_label>Seresis®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female volunteers between 18 and 30 years&#xD;
&#xD;
          -  With skin type I or skin type II&#xD;
&#xD;
          -  Body Mass Index &gt; 25&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Volunteers who have given their written informed consent according to Good Clinical&#xD;
             Practice (GCP) and local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious disorder that may interfere with her participation to the trial and&#xD;
             evaluation of the safety of the test drug (e.g. liver and/or renal disease,&#xD;
             hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication&#xD;
&#xD;
          -  Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant&#xD;
             treatment with any drug that may influence the trial symptomatology and may interfere&#xD;
             with evaluation of the safety of the test drug (e.g. vitamins and minerals&#xD;
             supplementation)&#xD;
&#xD;
          -  Relevant allergy or known hypersensitivity to the investigational drug or its&#xD;
             excipients&#xD;
&#xD;
          -  High performance sports people&#xD;
&#xD;
          -  Alcohol and drug abuse according to Diagnostic and Statistics Manual (DSM-IV)&#xD;
&#xD;
          -  Female volunteers in child-bearing age not using adequate means of birth control&#xD;
             (contraceptive pills, intrauterine device (IUDs), sterilization)&#xD;
&#xD;
          -  Pregnancy and/or lactation&#xD;
&#xD;
          -  Known abnormal values of the lab tests (if detected after enrolment, subjects will&#xD;
             continue the treatment provided there are no medical objections)&#xD;
&#xD;
          -  Abnormal values of Aspartate Transferase (SGOT/ASAT), Alanine Transferase&#xD;
             (SGPT/ALAT)-, Gamma-glutamyl transpeptidase, Low density Lipoproteins/Triglycerides&#xD;
             (LDL/TGL) levels in blood&#xD;
&#xD;
          -  Participation in another clinical trial within the last 4 weeks and concurrent&#xD;
             participation in another clinical trial&#xD;
&#xD;
          -  Specific dietary requirements that do not allow the volunteers to meet the dietary&#xD;
             guidelines set out for this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1135/1135.3_U01-1379.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</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/NCT02191813
org study id: 1135.3
nct id: NCT02191813
lead sponsor: 
Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by
      Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression)
      activated by UV radiation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
time frame: Day 84
measure: Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples
time frame: Day 84
measure: Changes in MMP-1 levels measured in skin samples
time frame: up to day 84
measure: Changes in MMP-9 levels measured in skin samples
time frame: up to day 84
measure: Changes in MMP-3 levels measured in skin samples
time frame: up to day 84
measure: Changes in pro-MMPs levels measured in skin samples
time frame: up to day 84
measure: Changes in tissue inhibitor (TIMP-1) levels measured in skin samples
time frame: up to day 84
measure: Heme oxygenase-1 level measured in skin samples
time frame: up to day 84
measure: Density of Langerhans cells measured in skin samples
time frame: up to day 84
measure: Cell proliferation and differentiation measured in skin samples
time frame: up to day 84
measure: Plasma levels of vitamin E
time frame: up to day 84
measure: Plasma levels of beta-carotene
time frame: up to day 84
measure: Number of subjects with adverse events
time frame: up to 112 days
measure: Number of subjects with abnormal changes in laboratory parameters
time frame: up to day 98
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: Day 84
measure: Assessment of tolerability by volunteer on a 4-point scale
time frame: Day 84
measure: Recall antigene (skin immune status) measured in the skin sample
time frame: up to 84 days
measure: Assessment of light sensitivity
time frame: up to 84 days
arm group label: Seresis®
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Seresis®
arm group label: Seresis®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1135/1135.3_U01-1379.pdf
description: Related Info
responsible party type: Sponsor