Clinical trial NCT01205061: Emervel® Deep Lidocaine vs. Juvederm® Ultra Plus 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® Deep Lidocaine Versus Juvederm® Ultra Plus in the Treatment of Moderate to Severe Facial Wrinkles and 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: 162
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 the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.

Detailed description: This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.

Eligibility criteria: Inclusion Criteria:

* The subject was a male or female 18 years of age or older
* The subject had bilateral nasolabial folds that, in the opinion of both the blinded evaluating investigator and the unblinded injecting investigator, was corrected with an injectable dermal implant
* The subject had the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold

Exclusion Criteria:

* The subject had 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 had a history of sensitivity to hyaluronic acid
* The subject had a history of sensitivity to lidocaine or other amide type anesthetics
* The subject was, 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 (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Secondary outcomes:
measure: Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection
timeFrame: Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)
measure: Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection
timeFrame: Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)
measure: Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection
timeFrame: Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)
measure: Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection
timeFrame: Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)
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 (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
measure: Participant Pain Assessment After the Initial Injection
timeFrame: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)
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 (At 3 weeks after initial injection)
measure: Number of Participants With Adverse Event (AEs)
timeFrame: From start of study drug administration up to 62 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Galderma research site
state: California
city: San Francisco
country: United States
facility: Galderma research site
state: California
city: New Haven
country: United States
facility: Galderma research site
state: Connecticut
city: Miami Beach
country: United States
facility: Galderma research site
state: Florida
city: Snellville
country: United States
facility: Galderma research site
state: Georgia
city: Hunt Valley
country: United States
facility: Galderma research site
state: Maryland
city: Warren
country: United States
facility: Galderma research site
state: Michigan
city: White Plains
country: United States
facility: Galderma research site
state: New York
city: Charlotte
country: United States
facility: Galderma research site
state: North Carolina
city: Nashville
country: United States
facility: Galderma research site
state: Tennessee
city: Plano
country: United States
facility: Galderma research site
state: Texas
Study officials:
affiliation: Galderma R&D
name: Clinical Operations, M.D.
role: STUDY_CHAIR
References: