<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/NCT03274154</url>
  </required_header>
  <id_info>
    <org_study_id>DERMING E0116</org_study_id>
    <nct_id>NCT03274154</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerance Evaluation of an Anti-age Food Supplement</brief_title>
  <official_title>Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled Clinical Study Versus Untreated Group</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>
      Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled&#xD;
      Clinical Study Versus Untreated Group&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study was to evaluate the anti-age activity of &quot;Pre-Hyaluron 465 Innēov&quot; a food&#xD;
      supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA&#xD;
      synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years&#xD;
      (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging&#xD;
      according to a reference photographic scale.&#xD;
&#xD;
      The study foresaw the evaluation of the study product activity versus a control group,&#xD;
      untreated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2016</start_date>
  <completion_date type="Actual">March 22, 2017</completion_date>
  <primary_completion_date type="Actual">March 22, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Crow's feet visual score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nasolabial folds visual score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surface microrelief regularity evaluation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Regularity grade was evaluated according to this score:&#xD;
= very regular&#xD;
= regular&#xD;
= irregular&#xD;
= very irregular</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin resistance to pinching clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin resistance to traction clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin recovery after pinching clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important&#xD;
= important&#xD;
= moderate&#xD;
= weak&#xD;
= very weak</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin dryness clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</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>Vascular homogeneity clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</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>
  <primary_outcome>
    <measure>Pigmentary homogeneity clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</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>
  <primary_outcome>
    <measure>Skin radiance clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Skin radiance was evaluated using a 10 points scale from very poor to good</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin plumpness clinical score variation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Skin plumpness was evaluated using a 10 points scale from very poor to good</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Superficial skin hydration</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).&#xD;
The measure of the skin capacitance properties is an indirect expression of its hydration level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep skin hydration</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of roughness profilometric parameters</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>Nasolabial folds 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>Tolerance evaluation</measure>
    <time_frame>Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)</time_frame>
    <description>The food supplement tolerance will be evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Moderate-severe Skin Aging/Photoaging</condition>
  <arm_group>
    <arm_group_label>Pre-Hyaluron 465 Innēov</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>43 caucasian female subjects have taken during a meal, for the first 4 months of trial,1 capsule and 1 tablet/die of the food supplement composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untreated group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>23 caucasian female subjects untreated</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Pre-Hyaluron 465 Innēov</intervention_name>
    <description>Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)</description>
    <arm_group_label>Pre-Hyaluron 465 Innēov</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex,&#xD;
&#xD;
          -  age 35-60 years (with preference for subjects over 45 years),&#xD;
&#xD;
          -  body mass index (BMI) 18-27,&#xD;
&#xD;
          -  caucasian healthy subjects with moderate-severe cutaneous aging/photoaging (score &gt; 3&#xD;
             of the reference photographic scale in appendix 8),&#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, make-up use,&#xD;
             face cosmetic and cleansing products,&#xD;
&#xD;
          -  agreeing not to apply any topical or take any oral product or nutritional&#xD;
             supplementation (vitamins and minerals) other than the investigational products, or&#xD;
             use face massages or other means known to improve skin wrinkles or skin qualities&#xD;
             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 actually 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;
          -  subjects not in menopause who do not use adequate contraceptive precautions in order&#xD;
             to avoid pregnancies during the study,&#xD;
&#xD;
          -  subjects not in menopause who do not accept to perform the pregnancy test at T0, T1,&#xD;
             T2 and T3,&#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;
        4.4.2. Dependent on a clinical condition 4.4.2.1. Dermatological disease,&#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;
          -  assumption 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>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 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/NCT03274154
org study id: DERMING E0116
nct id: NCT03274154
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Efficacy and Tolerance Evaluation of an Anti-age Food Supplement: a Randomized, Controlled
      Clinical Study Versus Untreated Group
Aim of the study was to evaluate the anti-age activity of "Pre-Hyaluron 465 Innēov" a food
      supplement, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA
      synthesis (manganese), taken for 4 consecutive months by female subjects aged 35-60 years
      (with preference for subjects over 45 years), with moderate-severe skin aging/photoaging
      according to a reference photographic scale.

      The study foresaw the evaluation of the study product activity versus a control group,
      untreated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Crow's feet visual score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
measure: Nasolabial folds visual score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Wrinkles grade was determined according to l'Oreal clinical standardized photographic scales
measure: Surface microrelief regularity evaluation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Regularity grade was evaluated according to this score:
= very regular
= regular
= irregular
= very irregular
measure: Skin resistance to pinching clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Skin resistance to traction clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Skin recovery after pinching clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Skin dryness clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Vascular homogeneity clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Pigmentary homogeneity clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
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: Skin radiance clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Skin radiance was evaluated using a 10 points scale from very poor to good
measure: Skin plumpness clinical score variation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Skin plumpness was evaluated using a 10 points scale from very poor to good
measure: Superficial skin hydration
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany).
The measure of the skin capacitance properties is an indirect expression of its hydration level.
measure: Deep skin hydration
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
measure: Determination of roughness profilometric parameters
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: Nasolabial folds 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: Tolerance evaluation
time frame: Basal visit (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), 5 months (T5)
description: The food supplement tolerance will be evaluated considering: any adverse event related to the study treatment, which occurred during the study; any judgement reported by the volunteers.
arm group label: Pre-Hyaluron 465 Innēov
arm group type: Experimental
description: 43 caucasian female subjects have taken during a meal, for the first 4 months of trial,1 capsule and 1 tablet/die of the food supplement composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese) .
arm group label: Untreated group
arm group type: No Intervention
description: 23 caucasian female subjects untreated
intervention type: Dietary Supplement
intervention name: Pre-Hyaluron 465 Innēov
description: Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)
arm group label: Pre-Hyaluron 465 Innēov
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Derming SRL
investigator full name: Adele Sparavigna
investigator title: Medical Doctor