Perception of Facial Expressions Following Correction of Wrinkles and Folds

NCT02573337 | Completed Phase 4

• 1 other identifier: 05DF1502
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Treatment impact on facial expressions

  Perception of naturalness

  1 month after touch-up treatment

Secondary Outcomes (6)

• 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

  1 month after touch-up

• Subject satisfaction with treatment outcome

  1 month after touch-up

• Nasolabial fold severity

  Before treatment and 2 weeks after first treatment and 1 month after touch-up

Study Arms (1)

Intradermal injection

EXPERIMENTAL

Emervel Classic Lidocaine and/or Emervel Deep Lidocaine

Device: Emervel Classic Lidocaine; Device: Emervel Deep Lidocaine

Interventions

Emervel Classic Lidocaine DEVICE

Treatment of wrinkles and folds

Intradermal injection

Emervel Deep Lidocaine DEVICE

Treatment of wrinkles and folds

Intradermal injection

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (3)

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Darmstadt, Germany

Location

Unknown Facility

Munich, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 9, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 25, 2022

Record last verified: 2016-01

Locations

DE (3)