Perception of Facial Expressions Following Correction of Wrinkles and Folds

A Multi-center, Non-comparative Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel Classic Lidocaine and Emervel Deep Lidocaine

The purpose of this study is to evaluate the perception of facial expressions following correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and Emervel Deep Lidocaine.

Study Overview

• Status: Completed
• Conditions: Wrinkles and Folds in Lower Face
• Intervention / Treatment: Device: Emervel Classic Lidocaine; Device: Emervel Deep Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
  • Darmstadt, Germany
  • Munich, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent
• NLFs assessed as moderate of severe using the WSRS
• Intent to undergo optimal correction of both NLFs
• Intent to undergo correction of at least one other wrinkle or fold in the lower face

Exclusion Criteria:

• Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction
• Subject who presents with severe midface volume loss
• Subject who presents with facial hair, e.g. beard, moustache, in the treatment area
• Woman who is pregnant or breast feeding or plans to become pregnant during the study
• Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment
• Previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
• Previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch
• Previous tissue augmenting therapy, contouring or revitalisation treatment with non-HA filler, e.g. Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), below the zygomatic arch within 24 months before treatment
• Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 12 months before treatment
• Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch within six (6) months before treatment
• Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intradermal injection; Emervel Classic Lidocaine and/or Emervel Deep Lidocaine	Device: Emervel Classic Lidocaine; Treatment of wrinkles and folds; Device: Emervel Deep Lidocaine; Treatment of wrinkles and folds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment impact on facial expressions	Perception of naturalness	1 month after touch-up treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety by assessment of local tolerability		2 weeks after first treatment
Safety by assessment of Adverse Events		0-13 months
Treating investigator satisfaction with treatment outcome	Questionnaire	1 month after touch-up
Subject satisfaction with treatment outcome	Questionnaires	1 month after touch-up
Nasolabial fold severity	WSRS photo scale	Before treatment and 2 weeks after first treatment and 1 month after touch-up
Aesthetic improvement of lower face	GAIS	1 month after touch-up

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 05DF1502