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

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: NCT02672644
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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. to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit).
  2. to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported
  3. to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30.
  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. to evaluate all adverse events during the course of the study

Condition or disease Intervention/treatment Phase
Nasolabial Folds Wrinkles Device: Emervel Classic Device: Emervel Deep Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Emervel Classic
Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling.
Device: Emervel Classic
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)

Experimental: Emervel Deep
Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling.
Device: Emervel Deep
Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).




Primary Outcome Measures :
  1. Subject-reported time of return to social engagement after initial treatment [ Time Frame: 30 days ]
    Time of return to social engagement (in hours)


Secondary Outcome Measures :
  1. Change from baseline to post-treatment follow-up time points in subject reported GAIS [ Time Frame: up to 30 days ]
    Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30

  2. Subject satisfaction with treatment outcome of the nasolabial folds [ Time Frame: 30 days ]
    Subject satisfaction with treatment assessments at baseline, day 14, and day 30

  3. Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS [ Time Frame: 30 days ]
    Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30

  4. Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS [ Time Frame: 30 days ]
    Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30

  5. Incidence rate of subjects with adverse events (AEs) [ Time Frame: 30 days ]
  6. Incidence rate of subjects with injection-related adverse events [ Time Frame: 30 days ]
    Injection-related adverse events recorded by the subject in study diary



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.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  1. Male or female subjects, 35 to 60 years of age
  2. Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator
  3. 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:

  1. use of oral/systemic contraceptives for at least 3 months prior to the start of the study; or
  2. use of an intrauterine device; or
  3. use of double barrier (e.g., condom or diaphragm and spermicidal foam/gel, condom and diaphragm); or
  4. use of contraceptive implants or injectables for at least 28 days prior to the start of the study; or
  5. partner with vasectomy at least 3 months prior to study start; or
  6. 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.

Key Exclusion Criteria:

  1. Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction
  2. Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
  3. Previous tissue augmenting therapy or contouring with permanent filler-type injectable product
  4. Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (12) months before treatment
  5. Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch, within six (6) months before treatment
  6. Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment
  7. Subject who presents with severe midface volume loss
  8. Subject has a beard or facial hair that, in the investigator's opinion, would interfere with the study injections and/or study assessments
  9. Woman who plans to become pregnant during the study
  10. Woman who is pregnant or breast feeding
  11. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
  12. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics
  13. Known/previous allergy or hypersensitivity to gram-positive bacterial proteins
  14. History of severe or multiple allergies manifested by anaphylaxis
  15. History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation within two (2) weeks before treatment
  16. 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
  17. Any medical condition or treatment that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion
  18. Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor company
  19. Participation in any clinical study within thirty (30) days before treatment

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): NCT02672644


Locations
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Canada, Quebec
Arthur Swift Research Inc.
Montreal, Quebec, Canada, H3Z 1B7
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Principal Investigator: Author Swift, MD Arthur Swift Research Inc
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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT02672644    
Other Study ID Numbers: GLI.04.SPR.US10346
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No