Evaluation of the Filler Performance on the Nasolabial Folds of Aliaxin® EV With and Without Lidocaine 0.3%

NCT03273556 | Completed

• 1 other identifier: E0817
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the filler performance on the nasolabial folds of Aliaxin® EV with and without lidocaine 0.3%: comparison within subjects (half face method)

Conditions

Nasolabial Folds Correction

Outcome Measures

Primary Outcomes (1)

• Wrinkle Severity Rating Scale (WSRS) grade variation from baseline

  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 visit (T0), Week 4 (T4)

Secondary Outcomes (3)

• The Global Aesthetic Improvement Scale (GAIS) grade variation from baseline

  Baseline visit (T0), Week 4 (T4)

• Self grading

  Immediately after the injection procedure (T0A), 2 hours after the injection procedure (T2h)

• Determination of profilometric parameters

  Baseline visit (T0), Week 4 (T4)

Study Arms (1)

Aliaxin® EV Essential Volume

EXPERIMENTAL

Comparison within subjects of Aliaxin® EV Essential Volume with and without Lidocaine 0.3%

Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%; Device: Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)

Interventions

Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3% DEVICE

The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list). A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.

Aliaxin® EV Essential Volume

Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) DEVICE

The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations . A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect.

Aliaxin® EV Essential Volume

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex;
• age 40-65 years;
• WSRS 2-4
• asking for nasolabial folds correction;
• execution of any medical/aesthetic procedure, including dental surgery, in the past that foresaw the use of lidocaine as local anesthetic
• 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 aesthetic 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;

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng S.r.l. Single Member Company

Monza, MB, 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: Medical Doctor

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 6, 2017
• Study Start: April 28, 2017
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09

Locations

IT (1)