<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/NCT03273556</url>
  </required_header>
  <id_info>
    <org_study_id>E0817</org_study_id>
    <nct_id>NCT03273556</nct_id>
  </id_info>
  <brief_title>Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%</brief_title>
  <official_title>Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: Comparison Within Subjects (Half Face Method)</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>
      Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without&#xD;
      lidocaine 0.3%: comparison within subjects (half face method)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that&#xD;
      foresaw the comparison within subjects of the investigational product versus investigational&#xD;
      product with Lidocaine 0.3% (half face method); assignation of right or left face side to the&#xD;
      two injective treatments was choose by the Investigator according to a previously defined&#xD;
      randomisation list.&#xD;
&#xD;
      Primary end point of the study was to evaluate the filling and bio-revitalizing activity on&#xD;
      nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.&#xD;
&#xD;
      It was also aim of this study to show if the addition of Lidocaine 0.3% to the&#xD;
      investigational product (extemporaneous mixture) could have reduced the discomfort/pain&#xD;
      sensation perceived by the subject during the injection procedure, without altering the&#xD;
      aesthetic performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2017</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Wrinkle Severity Rating Scale (WSRS) grade variation from baseline</measure>
    <time_frame>Baseline visit (T0), Week 4 (T4)</time_frame>
    <description>Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:&#xD;
Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.&#xD;
Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.&#xD;
Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; &lt;2mm visible fold when stretched.&#xD;
Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline</measure>
    <time_frame>Baseline visit (T0), Week 4 (T4)</time_frame>
    <description>Aesthetic improvement in the subjects' midface from their pretreatment state according to a five point scale:&#xD;
Very much improved: Optimal cosmetic result for the implant in this patient.&#xD;
Much improved: Marked improvement in appearance from initial condition, but not completely optimal for this patient. A touch up will slightly improve the result.&#xD;
Improved: Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.&#xD;
No change: The appearance is essentially the same as the original condition.&#xD;
Worse:The appearance in worst than the original condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self grading</measure>
    <time_frame>Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)</time_frame>
    <description>Immediately and 2 hours after the aesthetic procedure, each volunteers scored its own sensations thanks to a visual analogic scale (VAS 10 units length) as follow:&#xD;
Stinging (0= no stinging to 10= strong stinging)&#xD;
Itching (0= no itching to 10= strong itching)&#xD;
Tightening (0= no tightening to 10= strong tightening)&#xD;
Burning (0= no burning to 10= strong burning)&#xD;
Pain (0= no pain to 10= strong pain)&#xD;
Discomfort (0= no discomfort to 10= strong discomfort) In order to highlight any differences between the side treated with the investigational product and the one treated with the study product + lidocaine 0.3%, the VAS score will be expressed separately for each of the two treated sides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of profilometric parameters</measure>
    <time_frame>Baseline visit (T0), Week 4 (T4)</time_frame>
    <description>Variation from baseline of the nasolabial fold profilometric parameters versus baseline. Profilometric parameters are expressed in in micron.&#xD;
A picture of nasolabial fold area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters:Ra (average roughness) Rt (wrinkles total high), Rv (wrinkles maximum depth)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Nasolabial Folds Correction</condition>
  <arm_group>
    <arm_group_label>Aliaxin® EV Essential Volume</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%</intervention_name>
    <description>The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list).&#xD;
A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.</description>
    <arm_group_label>Aliaxin® EV Essential Volume</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)</intervention_name>
    <description>The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations .&#xD;
A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.</description>
    <arm_group_label>Aliaxin® EV Essential Volume</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female sex;&#xD;
&#xD;
          -  age 40-65 years;&#xD;
&#xD;
          -  WSRS 2-4&#xD;
&#xD;
          -  asking for nasolabial folds correction;&#xD;
&#xD;
          -  execution of any medical/aesthetic procedure, including dental surgery, in the past&#xD;
             that foresaw the use of lidocaine as local anesthetic&#xD;
&#xD;
          -  available and able to return to the study site for the post-procedural follow-up&#xD;
             examinations;&#xD;
&#xD;
          -  agreeing to present at each study visit without make-up;&#xD;
&#xD;
          -  accepting to not change their habits regarding food, physical activity, make-up use,&#xD;
             face cosmetic and cleansing products;&#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 aesthetic procedure);&#xD;
&#xD;
          -  Body Mass Index (BMI) variation (± 1) during the study period;&#xD;
&#xD;
          -  performing skin treatments for aesthetic correction (biomaterials implants, face&#xD;
             lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study&#xD;
             start;&#xD;
&#xD;
          -  performing permanent filler in the past;&#xD;
&#xD;
          -  change in the normal habits regarding food, physical activity, face cosmetic,&#xD;
             cleansing and make-up use 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 3 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 S.r.l. Single Member Company</name>
      <address>
        <city>Monza</city>
        <state>MB</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 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03273556
org study id: E0817
nct id: NCT03273556
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without
      lidocaine 0.3%: comparison within subjects (half face method)
Comparative, randomized, mono-centre spontaneous trial, under dermatological control, that
      foresaw the comparison within subjects of the investigational product versus investigational
      product with Lidocaine 0.3% (half face method); assignation of right or left face side to the
      two injective treatments was choose by the Investigator according to a previously defined
      randomisation list.

      Primary end point of the study was to evaluate the filling and bio-revitalizing activity on
      nasolabial folds of the product Aliaxin® EV Essential Volume, in women aged 40-65 years.

      It was also aim of this study to show if the addition of Lidocaine 0.3% to the
      investigational product (extemporaneous mixture) could have reduced the discomfort/pain
      sensation perceived by the subject during the injection procedure, without altering the
      aesthetic performance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wrinkle Severity Rating Scale (WSRS) grade variation from baseline
time frame: Baseline visit (T0), Week 4 (T4)
description: Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:
Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.
Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.
Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched.
Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
measure: The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline
time frame: Baseline visit (T0), Week 4 (T4)
description: Aesthetic improvement in the subjects' midface from their pretreatment state according to a five point scale:
Very much improved: Optimal cosmetic result for the implant in this patient.
Much improved: Marked improvement in appearance from initial condition, but not completely optimal for this patient. A touch up will slightly improve the result.
Improved: Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.
No change: The appearance is essentially the same as the original condition.
Worse:The appearance in worst than the original condition.
measure: Self grading
time frame: Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
description: Immediately and 2 hours after the aesthetic procedure, each volunteers scored its own sensations thanks to a visual analogic scale (VAS 10 units length) as follow:
Stinging (0= no stinging to 10= strong stinging)
Itching (0= no itching to 10= strong itching)
Tightening (0= no tightening to 10= strong tightening)
Burning (0= no burning to 10= strong burning)
Pain (0= no pain to 10= strong pain)
Discomfort (0= no discomfort to 10= strong discomfort) In order to highlight any differences between the side treated with the investigational product and the one treated with the study product + lidocaine 0.3%, the VAS score will be expressed separately for each of the two treated sides.
measure: Determination of profilometric parameters
time frame: Baseline visit (T0), Week 4 (T4)
description: Variation from baseline of the nasolabial fold profilometric parameters versus baseline. Profilometric parameters are expressed in in micron.
A picture of nasolabial fold area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters:Ra (average roughness) Rt (wrinkles total high), Rv (wrinkles maximum depth)
arm group label: Aliaxin® EV Essential Volume
arm group type: Experimental
description: Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%
intervention type: Device
intervention name: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%
description: The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list).
A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
arm group label: Aliaxin® EV Essential Volume
intervention type: Device
intervention name: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)
description: The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations .
A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.
arm group label: Aliaxin® EV Essential Volume
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
mesh term: Lidocaine