<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/NCT02191852</url>
  </required_header>
  <id_info>
    <org_study_id>1135.4</org_study_id>
    <nct_id>NCT02191852</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers</brief_title>
  <official_title>A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot 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 evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid&#xD;
      reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)&#xD;
      and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment&#xD;
      of individual antioxidant compounds contained in the product and to investigate whether or&#xD;
      not some of them accumulate in target tissues such as skin, BMCs and plasma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 1999</start_date>
  <primary_completion_date type="Actual">October 1999</primary_completion_date>
  <phase>Phase 1</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>Total antioxidant capacity in skin biopsies</measure>
    <time_frame>Day 0, Day 112</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total antioxidant capacity in skin biopsies</measure>
    <time_frame>Day 0, Day 56</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total antioxidant capacity in buccal mucosa cells (BMCs)</measure>
    <time_frame>Day 0, 14, 28, 42, 56, 84, 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total antioxidant capacity in plasma</measure>
    <time_frame>Day 0, 14, 28, 42, 56, 84, 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma levels of vitamin C and E and carotenoids</measure>
    <time_frame>Day 0, 14, 28, 42, 56, 84, 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of vitamin E and carotenoids in skin biopsies</measure>
    <time_frame>Day 0, 56, 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of vitamin E and carotenoids in BMCs</measure>
    <time_frame>Day 0, 14, 28, 42, 56, 84, 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>up to 119 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by investigator on a 4-point scale</measure>
    <time_frame>Day 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of tolerability by volunteers on a 4-point scale</measure>
    <time_frame>Day 112</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 112 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Seresis®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 capsules per day for a period of 16 consecutive weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seresis®</intervention_name>
    <arm_group_label>Seresis®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female volunteers between 18 and 30 years&#xD;
&#xD;
          -  With skin type II or skin type III&#xD;
&#xD;
          -  BMI &lt; 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&#xD;
&#xD;
          -  Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV&#xD;
             (DSM-IV)&#xD;
&#xD;
          -  Female volunteers in child-bearing age not using adequate means of birth control&#xD;
             (contraceptive pills, Intrauterine devices (IUDs), sterilisation)&#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 low density lipoproteins (LDL) and triglycerides (TGL) levels in&#xD;
             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/1135/1135.4_U00-0076.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/NCT02191852
org study id: 1135.4
nct id: NCT02191852
lead sponsor: 
Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid
      reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs)
      and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment
      of individual antioxidant compounds contained in the product and to investigate whether or
      not some of them accumulate in target tissues such as skin, BMCs and plasma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total antioxidant capacity in skin biopsies
time frame: Day 0, Day 112
measure: Total antioxidant capacity in skin biopsies
time frame: Day 0, Day 56
measure: Total antioxidant capacity in buccal mucosa cells (BMCs)
time frame: Day 0, 14, 28, 42, 56, 84, 112
measure: Total antioxidant capacity in plasma
time frame: Day 0, 14, 28, 42, 56, 84, 112
measure: Plasma levels of vitamin C and E and carotenoids
time frame: Day 0, 14, 28, 42, 56, 84, 112
measure: Levels of vitamin E and carotenoids in skin biopsies
time frame: Day 0, 56, 112
measure: Levels of vitamin E and carotenoids in BMCs
time frame: Day 0, 14, 28, 42, 56, 84, 112
measure: Number of subjects with adverse events
time frame: up to 119 days
measure: Assessment of tolerability by investigator on a 4-point scale
time frame: Day 112
measure: Assessment of tolerability by volunteers on a 4-point scale
time frame: Day 112
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 112 days
arm group label: Seresis®
arm group type: Experimental
description: 2 capsules per day for a period of 16 consecutive weeks
intervention type: Drug
intervention name: Seresis®
arm group label: Seresis®
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/1135/1135.4_U00-0076.pdf
description: Related Info
responsible party type: Sponsor