Clinical trial NCT02573337: Perception of Facial Expressions Following Correction of Wrinkles and Folds
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wrinkles and Folds in Lower Face
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 63
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Treatment impact on facial expressions
timeFrame: 1 month after touch-up treatment
Secondary outcomes:
measure: Safety by assessment of local tolerability
timeFrame: 2 weeks after first treatment
measure: Safety by assessment of Adverse Events
timeFrame: 0-13 months
measure: Treating investigator satisfaction with treatment outcome
timeFrame: 1 month after touch-up
measure: Subject satisfaction with treatment outcome
timeFrame: 1 month after touch-up
measure: Nasolabial fold severity
timeFrame: Before treatment and 2 weeks after first treatment and 1 month after touch-up
measure: Aesthetic improvement of lower face
timeFrame: 1 month after touch-up
Other outcomes:
Locations:
city: Cologne
country: Germany
city: Darmstadt
country: Germany
city: Munich
country: Germany
Study officials:
References: