Perception of Facial Expressions Following Correction of Wrinkles and Folds

Galderma

Status and phase

Completed

Phase 4

Conditions

Wrinkles and Folds in Lower Face

Treatments

Device: Emervel Classic Lidocaine

Device: Emervel Deep Lidocaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02573337

05DF1502

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)