Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Perception of Facial Expressions Following Correction of Wrinkles and Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573337
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

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.

Condition or disease Intervention/treatment Phase
Wrinkles and Folds in Lower Face Device: Emervel Classic Lidocaine Device: Emervel Deep Lidocaine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intradermal injection
Emervel Classic Lidocaine and/or Emervel Deep Lidocaine
Device: Emervel Classic Lidocaine
Treatment of wrinkles and folds

Device: Emervel Deep Lidocaine
Treatment of wrinkles and folds




Primary Outcome Measures :
  1. Treatment impact on facial expressions [ Time Frame: 1 month after touch-up treatment ]
    Perception of naturalness


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573337


Locations
Layout table for location information
Germany
Cologne, Germany
Darmstadt, Germany
Munich, Germany
Sponsors and Collaborators
Q-Med AB
Layout table for additonal information
Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT02573337    
Other Study ID Numbers: 05DF1502
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: January 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action