efficacy of an antiage aesthetic treatment for the middle and inferior third of the face

Conditions: Face Skin Laxity

Summary: primary endpoint of the study is to evaluate clinically and by non-invasive instrumental evaluations the aesthetic performance, on the third middle and inferior of the face, of "monodermà ha bio-revitalizing gel", an intradermal filler containing hyaluronic acid, combined to a low level laser therapy (lllt) to obtain a stable photo-cross-linking effect inside the dermis.


Eligibility criteria:
inclusion criteria: * female sex; * caucasian race; * non smokers; * no alcohol abuse and/or drug use; * 40-65 years; * fvls 2-4 ; * available and able to return to the study site for the post-procedural follow-up examinations; * accepting not to change their habits regarding food, physical activity, cosmetic and cleansing products for the face; * accepting not to expose their face to strong uv irradiation (uv session and/or sun bathes) during the entire duration of the study, without appropriate sun protection; * accepting to sign the informed consent form. exclusion criteria: * pregnancy (only for female subjects not in menopause); * lactation (only for female subjects not in menopause); * smokers; * alcohol abuse and/or drug use; * female subjects not in menopause, who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; * female subjects not in menopause, who do not accept to perform the pregnancy test at t0 and t1 (before the 1st and the 2nd aesthetic procedure); * body mass index (bmi) variation (± 1) during the study period; * having performed face treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 6 months beginning of the study; * having used 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 filler or its ingredients, including delayed hypersensitivity to hyaluronic acid and granulomatous reactions (to be assessed by the investigator during the baseline); * subjects whose insufficient adhesion to the study protocol is foreseeable; * participation in a similar study currently or during the previous 9 months; * dermatitis; * presence of cutaneous disease on the tested area, as lesions, scars, malformations; * subjects that tend to develop hypertrophic scars; * 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 started more than 1 year ago); * using of drugs able to influence the test results in the investigator's opinion.