Status:
COMPLETED
Evaluation of the Re-volumizing Performance of Aliaxin (New Trademark)
Lead Sponsor:
Derming SRL
Conditions:
Malar and Sub-malar Volume Deficiency
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
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 mechanis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03273660
Start Date
June 5 2017
End Date
March 13 2018
Last Update
July 27 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
DERMING
Milan, MI, Italy, 20900