Clinical trial NCT01205048: Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds
Official title: A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel Classic Lidocaine Versus Juvederm® Ultra in the Treatment of Moderate to Severe Facial Wrinkle Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Wrinkling
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.


Eligibility criteria: Inclusion Criteria:

* The subject is a male or female 18 years of age or older
* The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
* The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold

Exclusion Criteria:

* The subject has active skin disease or inflammation on or near a nasolabial fold that, in the Principal Investigator's opinion, would interfere with the study device injections and/or study assessments.
* The subject has a history of sensitivity to hyaluronic acid
* The subject has a history of sensitivity to lidocaine or other amide type anesthetics
* The subject is, in the Principal Investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.

Primary outcomes:
measure: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
timeFrame: Baseline, Week 24 after final initial injection
Secondary outcomes:
measure: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection
timeFrame: Baseline, Week 3 after final initial injection
measure: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection
timeFrame: Baseline, Week 12 after final initial injection
measure: Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection
timeFrame: Baseline, Week 36 after final initial injection
measure: Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection
timeFrame: Baseline, Week 48 after final initial injection
measure: Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
timeFrame: Baseline, Week 24 after final initial injection
measure: Participant Pain Assessment After the Initial Injection
timeFrame: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection
measure: Participant Pain Assessment After the Initial Touch-up Injection
timeFrame: At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From start of study drug administration up to 56 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Los Angeles
country: United States
facility: Skin Care & Laser Physicians of Beverly Hills
state: California
city: San Diego
country: United States
facility: FacesPlus Aesthetic Facility
state: California
city: San Diego
country: United States
facility: Therapeutics Research
state: California
city: Boca Raton
country: United States
facility: Steven Fagien
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Research Institute
state: Florida
city: Carmel
country: United States
facility: Laser & Skin Surgery Center in Indiana
state: Indiana
city: Glendale
country: United States
facility: Callender Center for Clinical Research
state: Maryland
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic & Laser Surgery
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Portland
country: United States
facility: Oregon Medical Research PC
state: Oregon
city: Austin
country: United States
facility: DermResearch
state: Texas
Study officials:
affiliation: Galderma R&D
name: Clinical Operations
role: STUDY_CHAIR
References: