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.

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.