Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep

NCT02672644 | Completed Phase 4

• 1 other identifier: GLI.04.SPR.US10346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.

1. 1.to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
2. 2.to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
3. 3.to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
4. 4.to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported
5. 5.to evaluate all adverse events during the course of the study

Conditions

Nasolabial Folds; Wrinkles

Outcome Measures

Primary Outcomes (1)

• Subject-reported time of return to social engagement after initial treatment

  Time of return to social engagement (in hours)

  30 days

Secondary Outcomes (6)

• Change from baseline to post-treatment follow-up time points in subject reported GAIS

  up to 30 days

• Subject satisfaction with treatment outcome of the nasolabial folds

  30 days

• Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS

  30 days

• Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS

  30 days

• Incidence rate of subjects with adverse events (AEs)

  30 days

Study Arms (2)

Emervel Classic

EXPERIMENTAL

Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling.

Device: Emervel Classic

Emervel Deep

EXPERIMENTAL

Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling.

Device: Emervel Deep

Interventions

Emervel Classic DEVICE

Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)

Emervel Classic

Emervel Deep DEVICE

Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).

Emervel Deep

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects, 35 to 60 years of age
• Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator
• Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
• Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1).
• \- If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows:
• use of oral/systemic contraceptives for at least 3 months prior to the start of the study; or
• use of an intrauterine device; or
• use of double barrier (e.g., condom or diaphragm and spermicidal foam/gel, condom and diaphragm); or
• use of contraceptive implants or injectables for at least 28 days prior to the start of the study; or
• partner with vasectomy at least 3 months prior to study start; or
• strict abstinence.
• Females of child bearing potential must have negative urine pregnancy test (UPT) at Day 1 and Day 14 if touch-up is to be performed.

You may not qualify if:

• Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction
• Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
• Previous tissue augmenting therapy or contouring with permanent filler-type injectable product
• Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (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
• Subject who presents with severe midface volume loss
• Subject has a beard or facial hair that, in the investigator's opinion, would interfere with the study injections and/or study assessments
• Woman who plans to become pregnant during the study
• Woman who is pregnant or breast feeding
• Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
• Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics
• Known/previous allergy or hypersensitivity to gram-positive bacterial proteins
• History of severe or multiple allergies manifested by anaphylaxis
• History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation within two (2) weeks before treatment

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Arthur Swift Research Inc.

Montreal, Quebec, H3Z 1B7, Canada

Location

Study Officials

• Author Swift, MD

  Arthur Swift Research Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 3, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 29, 2022

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)