Perception of Facial Expressions Following Correction of Wrinkles and Folds

NCT ID: NCT02573337

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-01-31

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.

Conditions

Wrinkles and Folds in Lower Face

Study Design

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

Study Groups

Intradermal injection

Emervel Classic Lidocaine and/or Emervel Deep Lidocaine

Group Type: EXPERIMENTAL

Emervel Classic Lidocaine

Intervention Type: DEVICE

Treatment of wrinkles and folds

Emervel Deep Lidocaine

Intervention Type: DEVICE

Treatment of wrinkles and folds

Interventions

Emervel Classic Lidocaine

Treatment of wrinkles and folds

Intervention Type: DEVICE

Emervel Deep Lidocaine

Treatment of wrinkles and folds

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cologne, , Germany

Darmstadt, , Germany

Munich, , Germany

Countries

Germany

Other Identifiers

05DF1502

Identifier Type: -

Identifier Source: org_study_id