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

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.

Study Overview

• Status: Completed
• Conditions: Malar and Sub-malar Volume Deficiency
• Intervention / Treatment: Device: Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20900
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity Rating Scale (WSRS) grade variation	Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line.; Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.; Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.; Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched.; Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.	Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)
Facial Volume Loss Scale (FVLS) grade variation	Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where: Grade 1: Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature.; Grade 2: An intermediate point between grade 1 and grade 3.; Grade 3: Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature.; Grade 4: An intermediate point between grade 3 and grade 5.; Grade 5: Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature.	Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photographic documentation (3D pictures)	Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.	Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)
Face volume variation	Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software	Baseline (T0), 3-4 weeks after the 1st injection procedure (T1),2 months after the 1st injection procedure (T2),3 months after the 1st injection procedure (T3),6 months after the 1st injection procedure (T4),9 months after the 1st injection procedure(T5)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2017
• Primary Completion (ACTUAL): March 13, 2018
• Study Completion (ACTUAL): March 13, 2018

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 4, 2017
• First Posted (ACTUAL): September 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: E0717

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No