Overview

This trial is active, not recruiting.

Condition wrinkles and folds in lower face
Treatments emervel classic lidocaine, emervel deep lidocaine
Phase phase 4
Sponsor Q-Med AB
Start date October 2015
End date March 2016
Trial size 63 participants
Trial identifier NCT02573337, 05DF1502

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Emervel Classic Lidocaine and/or Emervel Deep Lidocaine
emervel classic lidocaine
Treatment of wrinkles and folds
emervel deep lidocaine
Treatment of wrinkles and folds

Primary Outcomes

Measure
Treatment impact on facial expressions
time frame: 1 month after touch-up treatment

Secondary Outcomes

Measure
Safety by assessment of local tolerability
time frame: 2 weeks after first treatment
Safety by assessment of Adverse Events
time frame: 0-13 months
Treating investigator satisfaction with treatment outcome
time frame: 1 month after touch-up
Subject satisfaction with treatment outcome
time frame: 1 month after touch-up
Nasolabial fold severity
time frame: Before treatment and 2 weeks after first treatment and 1 month after touch-up
Aesthetic improvement of lower face
time frame: 1 month after touch-up

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Q-Med AB.