Perception of Facial Expressions Following Correction of Wrinkles and Folds

Phase 4

Completed

• Conditions: Wrinkles and Folds in Lower Face
• Interventions: Device: Emervel Classic Lidocaine; Device: Emervel Deep Lidocaine

• Registration Number: NCT02573337
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Status Verified: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2017-01
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intradermal injection	Emervel Classic Lidocaine	Emervel Classic Lidocaine and/or Emervel Deep Lidocaine
Intradermal injection	Emervel Deep Lidocaine	Emervel Classic Lidocaine and/or Emervel Deep Lidocaine

Primary Outcome Measures

Name	Time	Method
Treatment impact on facial expressions	1 month after touch-up treatment	Perception of naturalness

Secondary Outcome Measures

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