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

Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02672644
• Other study ID #: GLI.04.SPR.US10346
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds
• Wrinkles

Intervention

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)
• 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).

Locations

Country	Name	City	State
Canada	Arthur Swift Research Inc.	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported time of return to social engagement after initial treatment	Time of return to social engagement (in hours)	30 days
Secondary	Change from baseline to post-treatment follow-up time points in subject reported GAIS	Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30	up to 30 days
Secondary	Subject satisfaction with treatment outcome of the nasolabial folds	Subject satisfaction with treatment assessments at baseline, day 14, and day 30	30 days
Secondary	Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS	Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30	30 days
Secondary	Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS	Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30	30 days
Secondary	Incidence rate of subjects with adverse events (AEs)		30 days
Secondary	Incidence rate of subjects with injection-related adverse events	Injection-related adverse events recorded by the subject in study diary	30 days