<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/NCT03279159</url>
  </required_header>
  <id_info>
    <org_study_id>E0617</org_study_id>
    <nct_id>NCT03279159</nct_id>
  </id_info>
  <brief_title>Hydrating Efficacy and Tolerance Evaluation of a Face Cream</brief_title>
  <official_title>Hydrating Efficacy and Tolerance Evaluation of a Face Cream</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</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>
      Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and&#xD;
      hydrating activity of a face topic product, to be applied twice a day, morning and evening,&#xD;
      for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the&#xD;
      inclusion and exclusion criteria required by the study procedure .&#xD;
&#xD;
      It was also aim of this study to evaluate the hydrating activity of a single product&#xD;
      application on the skin damaged by repeated stripping corneum (short term evaluation versus&#xD;
      untreated control area).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">May 25, 2017</completion_date>
  <primary_completion_date type="Actual">May 25, 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>Change of superficial skin hydration after a single product application</measure>
    <time_frame>Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)</time_frame>
    <description>Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of transepidermal water loss (TEWL) after a single product application</measure>
    <time_frame>Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)</time_frame>
    <description>Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of superficial skin hydration after repeated product application</measure>
    <time_frame>Baseline (T0), 4 weeks (T4), 8 weeks (T8)</time_frame>
    <description>Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of deep skin hydration after repeated product application</measure>
    <time_frame>Baseline (T0), 4 weeks (T4), 8 weeks (T8)</time_frame>
    <description>Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Dry and Damaged Skin</condition>
  <arm_group>
    <arm_group_label>Jaluronius CS cream (Difa Cooper S.p.a, Italy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Jaluronius CS cream short term evaluation</intervention_name>
    <description>Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).</description>
    <arm_group_label>Jaluronius CS cream (Difa Cooper S.p.a, Italy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Jaluronius CS cream long term evaluation</intervention_name>
    <description>Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)</description>
    <arm_group_label>Jaluronius CS cream (Difa Cooper S.p.a, Italy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both sexes,&#xD;
&#xD;
          -  age 45-60 years,&#xD;
&#xD;
          -  caucasian subjects,&#xD;
&#xD;
          -  agreeing to present at each study visit without make-up,&#xD;
&#xD;
          -  accepting to follow the instructions received by the investigator,&#xD;
&#xD;
          -  accepting to not change their habits regarding food, physical activity, face cleansing&#xD;
             and make- up use,&#xD;
&#xD;
          -  agreeing not to apply or take any product or use face massages or other means known to&#xD;
             improve skin wrinkle and skin qualities during the entire duration of the study,&#xD;
&#xD;
          -  accepting not to expose their face to strong UV irradiation (UV session, or sun&#xD;
             bathes), during the entire duration of the study,&#xD;
&#xD;
          -  no participation in a similar study currently or during the previous 3 months&#xD;
&#xD;
          -  accepting to sign the Informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy (only for female subjects),&#xD;
&#xD;
          -  lactation (only for female subjects),&#xD;
&#xD;
          -  sensitivity to the test product or its ingredients (to be assessed by the investigator&#xD;
             during the baseline visit),&#xD;
&#xD;
          -  subjects whose insufficient adhesion to the study protocol is foreseeable.&#xD;
&#xD;
          -  presence of cutaneous disease on the tested area as lesions, scars, malformations,&#xD;
&#xD;
          -  recurrent facial/labial herpes,&#xD;
&#xD;
          -  clinical and significant skin condition on the test area (e.g. active eczema,&#xD;
             dermatitis, psoriasis etc.).&#xD;
&#xD;
          -  endocrine disease,&#xD;
&#xD;
          -  hepatic disorder,&#xD;
&#xD;
          -  renal disorder,&#xD;
&#xD;
          -  cardiac disorder,&#xD;
&#xD;
          -  pulmonary disease,&#xD;
&#xD;
          -  cancer,&#xD;
&#xD;
          -  neurological or psychological disease,&#xD;
&#xD;
          -  inflammatory/immunosuppressive disease,&#xD;
&#xD;
          -  drug allergy.&#xD;
&#xD;
          -  anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic&#xD;
             corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of&#xD;
             hormonal treatment starting more than 1 year ago),&#xD;
&#xD;
          -  using of drugs or dietary supplements able to influence the test results in the&#xD;
             investigator opinion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DERMING</name>
      <address>
        <city>Monza</city>
        <state>Monza-brianza</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Derming SRL</investigator_affiliation>
    <investigator_full_name>Adele Sparavigna</investigator_full_name>
    <investigator_title>Dermatologist, Principal Investigator</investigator_title>
  </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/NCT03279159
org study id: E0617
nct id: NCT03279159
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and
      hydrating activity of a face topic product, to be applied twice a day, morning and evening,
      for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the
      inclusion and exclusion criteria required by the study procedure .

      It was also aim of this study to evaluate the hydrating activity of a single product
      application on the skin damaged by repeated stripping corneum (short term evaluation versus
      untreated control area).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of superficial skin hydration after a single product application
time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
description: Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after a single product application on the skin area damaged by corneum stripping
measure: Change of transepidermal water loss (TEWL) after a single product application
time frame: Immediately after stripping (T0i), 1 hour after product application (T1h), 8 hours after product application (T8h), 24 hours after product application (T24h)
description: Variation of transepidermal water loss value measured with Tewameter® TM300 (MPA 5 Courage-Khazaka, Germany) after a single product application on the skin area damaged by corneum stripping
measure: Change of superficial skin hydration after repeated product application
time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
description: Variation of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany) after repeated product application on the face
measure: Change of deep skin hydration after repeated product application
time frame: Baseline (T0), 4 weeks (T4), 8 weeks (T8)
description: Variation of tissue dielectric constant value of deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland) after repeated product application on the face
arm group label: Jaluronius CS cream (Difa Cooper S.p.a, Italy)
arm group type: Experimental
intervention type: Other
intervention name: Jaluronius CS cream short term evaluation
description: Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).
arm group label: Jaluronius CS cream (Difa Cooper S.p.a, Italy)
intervention type: Other
intervention name: Jaluronius CS cream long term evaluation
description: Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)
arm group label: Jaluronius CS cream (Difa Cooper S.p.a, Italy)
criteria: 
gender: All
minimum age: 45 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Derming SRL
investigator full name: Adele Sparavigna
investigator title: Dermatologist, Principal Investigator