<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/NCT03833687</url>
  </required_header>
  <id_info>
    <org_study_id>E0918</org_study_id>
    <nct_id>NCT03833687</nct_id>
  </id_info>
  <brief_title>Aesthetic Performance of an Injective Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen</brief_title>
  <official_title>Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen</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>
      The objective of this study was to investigate the aesthetic performance of the Hyaluronic&#xD;
      acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique&#xD;
      (&quot;BAP&quot; technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness&#xD;
      of the abdomen and inner arms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2018</start_date>
  <completion_date type="Actual">February 6, 2019</completion_date>
  <primary_completion_date type="Actual">February 6, 2019</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 from baseline of arm skin roughness and laxity clinical grade</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of abdomen skin roughness and laxity clinical grade</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of superficial skin hydration</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>Skin electrical capacitance value was measured mono-laterally on the right or left inner arm and hemiabdomen with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of deep skin hydration</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm and hemiabdomen with MoistureMeterD (Delfin Technologies, Kuopio - Finland)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of skin density</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>A little skin area of about 7 cm2 (at level of inner arm was pinched, in standardized conditions, using a specific device. Because of this &quot;pinch&quot; the skin profile changes depending on cutaneous density; when the skin is slack the &quot;pinch&quot; forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of skin plastoelasticity</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>Superficial and deep skin plastoelasticity was measured mono-laterally on the right or left inner arm and hemiabdomen with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of photographic documentation</measure>
    <time_frame>Baseline (T0), 1 month (T1), 4 months (T2)</time_frame>
    <description>2D pictures of the abdomen and inner arm</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Skin Flaccidity and Roughness of the Abdomen and Inner Arms</condition>
  <arm_group>
    <arm_group_label>Profhilo®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 1st treatment was performed during the basal visit and repeated after 1 month.&#xD;
3 mL of Profhilo® for each brachial zone, 1.5 mL for hemiabdomen was injected into the middle-deep dermis by needle (29 G) using a bolus technique called &quot;BAP&quot; (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 horizontal-levels for each tested areas (3-4-3 injection points respectively for the 1st, the 2nd and the 3rd horizontal-level). The amount of product to be injected was of 0.3 ml for each point.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Profhilo®</intervention_name>
    <description>Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride.</description>
    <arm_group_label>Profhilo®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex;&#xD;
&#xD;
          -  age 40-65 years;&#xD;
&#xD;
          -  3-4 abdomen and inner arm roughness/laxity grade according to a clinical reference&#xD;
             scale;&#xD;
&#xD;
          -  asking for abdomen and inner arms laxity and roughness restoration;&#xD;
&#xD;
          -  available and able to return to the study site for the post-procedural follow-up&#xD;
             examinations;&#xD;
&#xD;
          -  accepting to not change their habits regarding food, physical activity, cosmetic and&#xD;
             cleansing products for the body;&#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, without appropriate sun protection;&#xD;
&#xD;
          -  accepting to sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  lactation;&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  alcohol or drug abusers;&#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&#xD;
             (before the 1st aesthetic procedure) and at T1 (1 month after the 1st injection&#xD;
             treatment execution, before the 2nd aesthetic procedure);&#xD;
&#xD;
          -  Body Mass Index (BMI) variation (± 1) during the study period;&#xD;
&#xD;
          -  performing skin treatments for abdominal and brachial zone aesthetic correction&#xD;
             (carboxytherapy injections, body lifting, laser, infrared light, bipolar&#xD;
             radiofrequency, vacuum and mechanical massage) in the 6 months prior to the study&#xD;
             start;&#xD;
&#xD;
          -  aesthetic surgical procedure on abdominal and brachial zone in the past;&#xD;
&#xD;
          -  change in the normal habits regarding food, physical activity, cosmetic products and&#xD;
             cleansing for the body during the month preceding the test;&#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;
          -  participation in a similar study currently or during the previous 6 months.&#xD;
&#xD;
          -  Dermatitis;&#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;
             psoriasis, severe rosacea, scleroderma, local infections and severe acne).&#xD;
&#xD;
          -  Diabetes;&#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;
          -  Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic&#xD;
             corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of&#xD;
             contraceptive or hormonal treatment starting more than 1 year ago);&#xD;
&#xD;
          -  using of drugs able to influence the test results in the investigator opinion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DERMING</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20159</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</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/NCT03833687
org study id: E0918
nct id: NCT03833687
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study was to investigate the aesthetic performance of the Hyaluronic
      acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique
      ("BAP" technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness
      of the abdomen and inner arms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline of arm skin roughness and laxity clinical grade
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).
measure: Change from baseline of abdomen skin roughness and laxity clinical grade
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).
measure: Change from baseline of superficial skin hydration
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: Skin electrical capacitance value was measured mono-laterally on the right or left inner arm and hemiabdomen with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.
measure: Change from baseline of deep skin hydration
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the right or left inner arm and hemiabdomen with MoistureMeterD (Delfin Technologies, Kuopio - Finland)
measure: Change from baseline of skin density
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: A little skin area of about 7 cm2 (at level of inner arm was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.
measure: Change from baseline of skin plastoelasticity
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: Superficial and deep skin plastoelasticity was measured mono-laterally on the right or left inner arm and hemiabdomen with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).
measure: Change from baseline of photographic documentation
time frame: Baseline (T0), 1 month (T1), 4 months (T2)
description: 2D pictures of the abdomen and inner arm
arm group label: Profhilo®
arm group type: Experimental
description: The 1st treatment was performed during the basal visit and repeated after 1 month.
3 mL of Profhilo® for each brachial zone, 1.5 mL for hemiabdomen was injected into the middle-deep dermis by needle (29 G) using a bolus technique called "BAP" (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 horizontal-levels for each tested areas (3-4-3 injection points respectively for the 1st, the 2nd and the 3rd horizontal-level). The amount of product to be injected was of 0.3 ml for each point.
intervention type: Device
intervention name: Profhilo®
description: Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride.
arm group label: Profhilo®
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 65 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