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CompletedNCT03273660Updated Jul 27, 2018

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

An interventional study of Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.) in Malar and Sub-malar Volume Deficiency, sponsored by Derming SRL. Completed at 1 site in Italy. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.

Sponsored by Derming SRL · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
40 Years to 65 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Malar and Sub-malar Volume Deficiency
03

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

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

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

Interventions

  • DeviceAliaxin (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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

  2. 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.

    Time frame: 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 outcomes

  1. Photographic documentation (3D pictures)

    Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.

    Time frame: 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)

  2. Face volume variation

    Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software

    Time frame: 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)

06

Study locations

1 site
  • DERMING
    Milano, MI 20900, Italy
07

Registry details

Key details

Study ID
NCT03273660
Lead sponsor
Derming SRL
Responsible party
Adele Sparavigna (Dermatologist, Principal Investigator, Derming SRL) — Principal investigator
First posted
Sep 6, 2017
Start date
Jun 5, 2017
Primary completion
Mar 13, 2018
Completion
Mar 13, 2018
Last update
Jul 27, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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