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Completed

NCT Number: NCT02573337

Perception of Facial Expressions Following Correction of Wrinkles and Folds

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cologne, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emervel Classic Lidocaine

Device

Treatment of wrinkles and folds

Emervel Deep Lidocaine

Device

Treatment of wrinkles and folds

Primary outcomes

  1. Treatment impact on facial expressions

    Time frame: 1 month after touch-up treatment

    Perception of naturalness

Secondary outcomes

  1. Safety by assessment of local tolerability

    Time frame: 2 weeks after first treatment

  2. Safety by assessment of Adverse Events

    Time frame: 0-13 months

  3. Treating investigator satisfaction with treatment outcome

    Time frame: 1 month after touch-up

    Questionnaire

  4. Subject satisfaction with treatment outcome

    Time frame: 1 month after touch-up

    Questionnaires

  5. Nasolabial fold severity

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

    WSRS photo scale

  6. Aesthetic improvement of lower face

    Time frame: 1 month after touch-up

    GAIS

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 9, 2015
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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