<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/NCT03276897</url>
  </required_header>
  <id_info>
    <org_study_id>E0517</org_study_id>
    <nct_id>NCT03276897</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerance Evaluation of a &quot;Revitalizing&quot; Face Treatment</brief_title>
  <official_title>Efficacy and Tolerance Evaluation of a &quot;Revitalizing&quot; Face Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Derming SRL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Derming SRL</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy and Tolerance Evaluation of a&quot;revitalizing&quot; face treatment consisting of a day and a&#xD;
      night cream&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the&#xD;
      activity of a &quot;revitalizing&quot; face treatment consisting of a day and a night cream, applied&#xD;
      for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with&#xD;
      aging/photo aging of moderate grade.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 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 wrinkles grade, around the eyes (Crow's feet)</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where:&#xD;
Type 1: early wrinkles&#xD;
Type 2: wrinkle in motion&#xD;
Type 3: wrinkles at rest&#xD;
Type 4: Only wrinkles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of wrinkles grade of nasolabial folds</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where:&#xD;
Grade 1: no wrinkles&#xD;
Grade 2: just perceptible wrinkles&#xD;
Grade 3: shallow wrinkles&#xD;
Grade 4: moderately deep wrinkles&#xD;
Grade 5: deep wrinkles, well-defined folds&#xD;
Grade 6: very deep wrinkles, redundant fold</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of skin surface microrelief's regularity</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where:&#xD;
Grade 1:very regular&#xD;
Grade 2: regular&#xD;
Grade 3: irregular&#xD;
Grade 4: very irregular.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of skin resistance to pinching clinical score</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score:&#xD;
0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of skin resistance to traction clinical score</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score:&#xD;
0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of skin recovery after pinching clinical score</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score:&#xD;
0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of skin dryness clinical score</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Clinical evaluation of skin dryness was performed according to the following score:&#xD;
0 = very hydrated skin&#xD;
= hydrated skin&#xD;
= normal skin&#xD;
= kindly dry skin&#xD;
= dry skin&#xD;
= very dry skin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of vascular and pigmentary homogeneity clinical score</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score:&#xD;
0 = very homogeneous&#xD;
= homogeneous&#xD;
= quite not homogeneous&#xD;
= not homogeneous&#xD;
= very not homogeneous&#xD;
= marked not homogeneous</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of roughness profilometric parameters</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Photographic documentation (3D pictures)</measure>
    <time_frame>Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)</time_frame>
    <description>Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Face Aging/Photo Aging of Moderate Grade</condition>
  <arm_group>
    <arm_group_label>Nutriage SPF 30 day cream and Nutriage night cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)</intervention_name>
    <description>A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage</description>
    <arm_group_label>Nutriage SPF 30 day cream and Nutriage night cream</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex,&#xD;
&#xD;
          -  age 35-60 years,&#xD;
&#xD;
          -  Caucasian subjects,&#xD;
&#xD;
          -  presence of moderate face ritidosis,&#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,&#xD;
&#xD;
          -  lactation,&#xD;
&#xD;
          -  sensitivity to the test products or their ingredients (to be assessed by the&#xD;
             investigator 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>Female</gender>
    <minimum_age>35 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>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 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>Medical Doctor</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/NCT03276897
org study id: E0517
nct id: NCT03276897
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a
      night cream
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the
      activity of a "revitalizing" face treatment consisting of a day and a night cream, applied
      for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with
      aging/photo aging of moderate grade.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of wrinkles grade, around the eyes (Crow's feet)
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where:
Type 1: early wrinkles
Type 2: wrinkle in motion
Type 3: wrinkles at rest
Type 4: Only wrinkles
measure: Change of wrinkles grade of nasolabial folds
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where:
Grade 1: no wrinkles
Grade 2: just perceptible wrinkles
Grade 3: shallow wrinkles
Grade 4: moderately deep wrinkles
Grade 5: deep wrinkles, well-defined folds
Grade 6: very deep wrinkles, redundant fold
measure: Change of skin surface microrelief's regularity
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where:
Grade 1:very regular
Grade 2: regular
Grade 3: irregular
Grade 4: very irregular.
measure: Change of skin resistance to pinching clinical score
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
= important
= moderate
= weak
= very weak
measure: Change of skin resistance to traction clinical score
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
= important
= moderate
= weak
= very weak
measure: Change of skin recovery after pinching clinical score
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: The evaluation was performed at level of cheek (malar region) according to the following score:
0 = very important
= important
= moderate
= weak
= very weak
measure: Change of skin dryness clinical score
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Clinical evaluation of skin dryness was performed according to the following score:
0 = very hydrated skin
= hydrated skin
= normal skin
= kindly dry skin
= dry skin
= very dry skin
measure: Change of vascular and pigmentary homogeneity clinical score
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score:
0 = very homogeneous
= homogeneous
= quite not homogeneous
= not homogeneous
= very not homogeneous
= marked not homogeneous
measure: Change of roughness profilometric parameters
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.
measure: Photographic documentation (3D pictures)
time frame: Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)
description: Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.
arm group label: Nutriage SPF 30 day cream and Nutriage night cream
arm group type: Experimental
description: Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months.
intervention type: Other
intervention name: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)
description: A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage
arm group label: Nutriage SPF 30 day cream and Nutriage night cream
criteria: 
gender: Female
minimum age: 35 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: Medical Doctor