Evaluation of the Re-volumizing Performance of Aliaxin (New Trademark)

Derming

Status

Completed

Conditions

Malar and Sub-malar Volume Deficiency

Treatments

Device: Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.)

Study type

Interventional

Funder types

Other

Identifiers

NCT03273660

E0717

Details and patient eligibility

About

Aim of the study is to evaluate the re-volumizing performance and the duration effect of the product Aliaxin (new trademark) in women aged 40-65 years with midface volume defects due to aging mechanism.

Enrollment

22 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

female sex;
age 40-65 years;
FVLS 2-4;
asking for midface volume restoration;
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 first aesthetic procedure) and at T1 (3-4 weeks after the first injection treatment execution, before the touch-up aestetic 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.