Emervel for the Correction of Lower Face Wrinkles & Folds

NCT ID: NCT02718040

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-08-31

Brief Summary

This study is designed to

1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment

2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment

3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment

4. evaluate aesthetic improvement, by subject and treating investigator assessments

5. evaluate subject satisfaction

6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment

7. evaluate marionette lines (MLs) severity, by treating investigator assessment

8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis

9. evaluate all adverse events reported during the study.

Conditions

Nasolabial Folds; Marionette Lines; Wrinkles

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emervel Treatment Group

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

Group Type: EXPERIMENTAL

Emervel Classic and/or Deep Treatment Group

Intervention Type: 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)

Interventions

Emervel Classic and/or Deep Treatment Group

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)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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).

2. Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.

3. 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.

Exclusion Criteria

1. Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.

2. Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.

3. Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.

4. Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.

5. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.

6. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.

7. Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.

8. Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).

9. 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Mashburn

Role: STUDY_DIRECTOR

Galderma Laboratories

Other Identifiers

GLI.04.SPR.US10345

Identifier Type: -

Identifier Source: org_study_id