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

NCT ID: NCT03273660

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2018-03-13

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 mechanism.

Conditions

Malar and Sub-malar Volume Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure.

0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm).

A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry.

Interventions

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

First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure.

0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm).

A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Dermatologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DERMING

Milan, MI, Italy

Countries

Italy

Other Identifiers

E0717

Identifier Type: -

Identifier Source: org_study_id