NCT02573337
Completed
Phase 4
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
ConditionsWrinkles and Folds in Lower Face
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 63
- Primary Endpoint
- Treatment impact on facial expressions
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Treatment impact on facial expressions
Time Frame: 1 month after touch-up treatment
Perception of naturalness
Secondary Outcomes
- Safety by assessment of local tolerability(2 weeks after first treatment)
- Aesthetic improvement of lower face(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)
- Safety by assessment of Adverse Events(0-13 months)
- Treating investigator satisfaction with treatment outcome(1 month after touch-up)
Investigators
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