evaluation of the filler performance on the nasolabial folds of aliaxin® ev with and without lidocaine 0.3%

Conditions: Nasolabial Folds Correction

Summary: 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.

Eligibility criteria:
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.