face photoaging: efficacy and tolerance evaluation of an intradermal injective treatment

Conditions: Face Skin Photoaging

Summary: efficacy and tolerance evaluation of an intradermal injective treatment

primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of sunekos ® 200 injectable treatment on main sign of face skin photoaging; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.

Eligibility criteria:
inclusion criteria: * - female sex; * age 45-65 years; * mild/moderate cutaneous photoaging according to a reference photographic scale (see appendix 8) * skin phototype i, ii and iii according to fitzpatrick's classification, with a preference to grade ii-iii (see par. 8.1) * 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; * accepting to sign the informed consent form. exclusion criteria: * dependent on the volunteers' characteristics * pregnancy; * lactation; * subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study; * body mass index (bmi) variation (± 1) during the study period; * subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (t4i) and 2 months (t2m) after the first biomineralizing treatment execution; * performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 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 actually or during the previous 6 months. * 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, dermatitis, psoriasis etc.). * diabetes * endocrine disease * hepatic disorder * renal disorder * cardiac disorder * pulmonary disease * cancer * neurological or psychological disease * inflammatory/immunosuppressive disease * drug allergy. * anti-inflammatory 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); * assumption of drugs able to influence the test results in the investigator opinion.