Emervel for the Correction of Lower Face Wrinkles & Folds

NCT02718040 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10345
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to

1. 1.evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
2. 2.evaluate naturalness of facial expressions (photographs), by treating investigator assessment
3. 3.evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
4. 4.evaluate aesthetic improvement, by subject and treating investigator assessments
5. 5.evaluate subject satisfaction
6. 6.evaluate nasolabial fold (NLF) severity, by treating investigator assessment
7. 7.evaluate marionette lines (MLs) severity, by treating investigator assessment
8. 8.evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
9. 9.evaluate all adverse events reported during the study.

Conditions

Nasolabial Folds; Marionette Lines; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Naturalness of Expression in Motion (2D Video)

  Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator

  42 days

Secondary Outcomes (9)

• Number of Subjects With Naturalness of Expression (Photographs)

  42 days

• Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)

  42 days

• Number of Subjects Reporting Global Improvement (Subject)

  42 days

• Number of Subjects Demonstrating Global Improvement (Treating Investigator)

  42 days

• Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural

  42 days

Study Arms (1)

Emervel Treatment Group

EXPERIMENTAL

Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep

Device: Emervel Classic and/or Deep Treatment Group

Interventions

Emervel Classic and/or Deep Treatment Group DEVICE

Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)

Emervel Treatment Group

Eligibility Criteria

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

You may qualify if:

• Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
• Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
• Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.

You may not qualify if:

• Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
• Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
• Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
• Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
• Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
• Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.
• Other condition preventing the subject from entering the study in the treating investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Sponsors & Collaborators

• Galderma R&D: lead

Results Point of Contact

• Title: Jay Mashburn
• Organization: Galderma Laboratories

jay.mashburn@galderma.com

Study Officials

• Jay Mashburn

  Galderma Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: March 24, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 1, 2022
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share