NCT03273660

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2018

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

September 4, 2017

Last Update Submit

July 26, 2018

Conditions

Malar and Sub-malar Volume Deficiency

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Photographic documentation (3D pictures)

    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

    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)

Study Arms (1)

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

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

Interventions

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

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

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DERMING

Milan, MI, 20900, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dermatologist, Principal Investigator

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

June 5, 2017

Primary Completion

March 13, 2018

Study Completion

March 13, 2018

Last Updated

July 27, 2018

Record last verified: 2018-07

Locations

IT(1)