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

Malar and Sub-malar Volume Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273660
• Other study ID #: E0717
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: July 2018
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malar and Sub-malar Volume Deficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	DERMING	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)