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/NCT06037291</url>
    </required_header>
    <id_info>
      <org_study_id>IT0002762/21</org_study_id>
      <nct_id>NCT06037291</nct_id>
    </id_info>
    <brief_title>Assessement of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin</brief_title>
    <official_title>Assessment of the Soothing Effect of a Food Supplement on Sensitive and Reactive Skin. Double Blind Randomized Placebo-controlled Clinical Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seppic</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seppic</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 study is aimed to assess the soothing effect of a food supplement composed of Coriander&#xD;
        Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on&#xD;
        sensitive and reactive skin.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A double blind, parallel groups, placebo-controlled study is carried out on 80 female&#xD;
        subjects aged between 18 and 65 years old with sensitive and reactive skin.&#xD;
  &#xD;
        The study foresees 56 days of products intake. Evaluations of the parameters under study are&#xD;
        performed at baseline, after 14, 28 and 56 days of products consumption.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 15, 2021</start_date>
    <completion_date type="Actual">January 31, 2022</completion_date>
    <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
    <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Skin redness</measure>
      <time_frame>Baseline</time_frame>
      <description>Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin redness</measure>
      <time_frame>14 days</time_frame>
      <description>Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin redness</measure>
      <time_frame>28 days</time_frame>
      <description>Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Skin redness</measure>
      <time_frame>56 days</time_frame>
      <description>Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Skin stinging</measure>
      <time_frame>Baseline</time_frame>
      <description>Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin stinging</measure>
      <time_frame>14 days</time_frame>
      <description>Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin stinging</measure>
      <time_frame>28 days</time_frame>
      <description>Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin stinging</measure>
      <time_frame>56 days</time_frame>
      <description>Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythema index</measure>
      <time_frame>Baseline</time_frame>
      <description>Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythema index</measure>
      <time_frame>56 days</time_frame>
      <description>Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin TNF-alpha quantification (subgroup of 20 subjects)</measure>
      <time_frame>Baseline</time_frame>
      <description>Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin TNF-alpha quantification (subgroup of 20 subjects)</measure>
      <time_frame>56 days</time_frame>
      <description>Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-assessment of product efficacy</measure>
      <time_frame>56 days</time_frame>
      <description>Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Coriander Seed Oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dietary supplement - Coriander Seed Oil</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Dietary supplement - Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Coriander Seed Oil</intervention_name>
      <description>The study foresees the intake of 1 capsule per day during 56 days</description>
      <arm_group_label>Coriander Seed Oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>The study foresees the intake of 1 capsule per day during 56 days</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria :&#xD;
  &#xD;
            -  Good general health&#xD;
  &#xD;
            -  Caucasian ethnicity&#xD;
  &#xD;
            -  Female sex&#xD;
  &#xD;
            -  Phototype I to IV&#xD;
  &#xD;
            -  Sensitive and reactive skin (showing positive answer from 3-moderate to 4-strong to&#xD;
               stinging test performed with a 10% lactic acid solution)&#xD;
  &#xD;
            -  Age between 18 and 65 years old (subject with 18 and 65 years old can be included)&#xD;
  &#xD;
            -  Subjects who have not been recently involved in any other similar study (evaluation is&#xD;
               performed case by case by the experimenter but at least 1 month must be elapsed&#xD;
               between a previous study on food supplement)&#xD;
  &#xD;
            -  Willingness to use during all the study period only the products to be tested&#xD;
  &#xD;
            -  Willingness not to use similar products that could interfere with the product to be&#xD;
               tested&#xD;
  &#xD;
            -  Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity,&#xD;
               diet etc.)&#xD;
  &#xD;
            -  Subjects under effective contraception (oral/not oral) if women of childbearing&#xD;
               potential; not expected to be changed during the trial&#xD;
  &#xD;
            -  Subject aware of the study procedures and having signed an informed consent form&#xD;
  &#xD;
            -  Subjects who accept not to expose in intensive way to UV rays during the whole study&#xD;
               duration&#xD;
  &#xD;
            -  Subjects who have not involved in any sun test (for SPF evaluation) or tests that&#xD;
               provide skin irradiation since less than two months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject does not meet the inclusion criteria,&#xD;
  &#xD;
            -  Pregnant/breastfeeding female or who have planned a pregnancy during the study period&#xD;
  &#xD;
            -  Subjects under systemically pharmacological treatment&#xD;
  &#xD;
            -  Subjects under locally pharmacological treatment on the skin area monitored during the&#xD;
               test&#xD;
  &#xD;
            -  Subjects with congenital or acquired immunodeficiency&#xD;
  &#xD;
            -  Subjects under treatment with food supplements which could interfere with the&#xD;
               functionality of the product under study&#xD;
  &#xD;
            -  Subjects which show skin alterations on the monitored area which could interfere with&#xD;
               the functionality of the product under study&#xD;
  &#xD;
            -  Subjects considered as not adequate to participate to the study by the investigator&#xD;
  &#xD;
            -  Subjects with known or suspected sensitization to one or more test formulation&#xD;
               ingredients&#xD;
  &#xD;
            -  Adult protected by law (under control or hospitalized in public or private&#xD;
               institutions for reasons other than research, or incarcerated)&#xD;
  &#xD;
            -  Subjects not able to communicate or cooperate with the investigator for problems&#xD;
               related to language, mental retardation or impaired brain function&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ileana De Ponti</last_name>
      <role>Study Director</role>
      <affiliation>Complife Italia S.r.l</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Complife Italia srl</name>
        <address>
          <city>Milano</city>
          <zip>20024</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <!-- 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/NCT06037291
  org study id: IT0002762/21
  nct id: NCT06037291
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is aimed to assess the soothing effect of a food supplement composed of Coriander
        Seed Oil (CSO) in terms of reducing skin redness and skin discomfort (stinging feeling) on
        sensitive and reactive skin.
  A double blind, parallel groups, placebo-controlled study is carried out on 80 female
        subjects aged between 18 and 65 years old with sensitive and reactive skin.
  
        The study foresees 56 days of products intake. Evaluations of the parameters under study are
        performed at baseline, after 14, 28 and 56 days of products consumption.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Skin redness
  time frame: Baseline
  description: Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
  measure: Skin redness
  time frame: 14 days
  description: Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
  measure: Skin redness
  time frame: 28 days
  description: Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
  measure: Skin redness
  time frame: 56 days
  description: Induction of skin redness by skin stripping followed by the evaluation of skin color by CIELab color space (a* parameter)
  measure: Skin stinging
  time frame: Baseline
  description: Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
  measure: Skin stinging
  time frame: 14 days
  description: Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
  measure: Skin stinging
  time frame: 28 days
  description: Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
  measure: Skin stinging
  time frame: 56 days
  description: Induction of skin itching by a lactic acid solution followed by the self-assessment of stinging severity at different time points (0, 1, 2, 3, 4, 5, 7, 9, 12, 15 and 20 min) after the solution application using a defined 4-point clinical scale (1. No reaction; 2. Mild reaction; 3. Moderate reaction; 4. Severe reaction).
  measure: Erythema index
  time frame: Baseline
  description: Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.
  measure: Erythema index
  time frame: 56 days
  description: Induction of skin redness by UVA+UVB exposure followed by the evaluation of the erythema index (skin haemoglobin content) by Mexameter® 24h after UV exposure.
  measure: Skin TNF-alpha quantification (subgroup of 20 subjects)
  time frame: Baseline
  description: Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
  measure: Skin TNF-alpha quantification (subgroup of 20 subjects)
  time frame: 56 days
  description: Quantification of TNF-alpha concentration by Enzyme-Linked Immunosorbent Assay on skin stripping performed 24h after UV exposure (non-irradiated and irradiated area)
  measure: Self-assessment of product efficacy
  time frame: 56 days
  description: Questionnaire (10 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)
  arm group label: Coriander Seed Oil
  arm group type: Experimental
  description: Dietary supplement - Coriander Seed Oil
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Dietary supplement - Placebo
  intervention type: Dietary Supplement
  intervention name: Coriander Seed Oil
  description: The study foresees the intake of 1 capsule per day during 56 days
  arm group label: Coriander Seed Oil
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: The study foresees the intake of 1 capsule per day during 56 days
  arm group label: Placebo
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ileana De Ponti
  role: Study Director
  affiliation: Complife Italia S.r.l
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Hypersensitivity