Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%

Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%: Comparison Within Subjects (Half Face Method)

Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds Correction
• Intervention / Treatment: Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%; Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • DermIng S.r.l. Single Member Company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female sex;
• age 40-65 years;
• WSRS 2-4
• asking for nasolabial folds correction;
• execution of any medical/aesthetic procedure, including dental surgery, in the past that foresaw the use of lidocaine as local anesthetic
• available and able to return to the study site for the post-procedural follow-up examinations;
• agreeing to present at each study visit without make-up;
• accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
• accepting to sign the informed consent form

Exclusion Criteria:

• Pregnancy;
• lactation;
• smokers;
• alcohol or drug abusers;
• subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
• subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the aesthetic procedure);
• Body Mass Index (BMI) variation (± 1) during the study period;
• performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
• performing permanent filler in the past;
• change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test;
• sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
• subjects whose insufficient adhesion to the study protocol is foreseeable;
• participation in a similar study currently or during the previous 3 months.
• dermatitis;
• presence of cutaneous disease on the tested area, as lesions, scars, malformations;
• recurrent facial/labial herpes;
• clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
• diabetes;
• endocrine disease;
• hepatic disorder;
• renal disorder;
• cardiac disorder;
• pulmonary disease;
• cancer;
• neurological or psychological disease;
• inflammatory/immunosuppressive disease;
• drug allergy,
• anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago),
• using of drugs able to influence the test results in the investigator opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aliaxin® EV Essential Volume; Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%

Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%; 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.; Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) grade variation from baseline	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.	Baseline visit (T0), Week 4 (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline	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.	Baseline visit (T0), Week 4 (T4)
Self grading	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.	Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)
Determination of profilometric parameters	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)	Baseline visit (T0), Week 4 (T4)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: E0817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No