Trial Outcomes & Findings for Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds (NCT NCT00850889)

Results Overview

Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

1 day

Results posted on

2019-01-09

Participant Flow

Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008

Participant milestones

Participant milestones
Measure	Total Participants Each participant received Juvederm on one side of the face and Restylane on the other side.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Participants n=32 Participants Each participant received Juvederm on one side of the face and Restylane on the other side.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	51.8 years STANDARD_DEVIATION 7.82 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment Canada	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Subjects evaluated the pain associated with the procedure on an 11-point scale, where 0 is no pain and 10 is the worst pain imaginable.

Outcome measures

Outcome measures
Measure	Juvederm(R) Ultra Injectable Gel With Lidocaine n=32 Participants	Restylane(R) Injectable Gel n=32 Participants
Procedural Pain Score	2.0 units on a scale Standard Deviation 1.84	4.1 units on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: 1 day

A 5-point scale (-2 = Juvéderm with Lidocaine less painful than Restylane; -1 = Juvéderm with Lidocaine slightly less painful than Restylane; 0 = No difference; 1 = Juvéderm with Lidocaine slightly more painful than Restylane; 2 = Juvéderm with Lidocaine more painful than Restylane). Subjects selected one category from the scale; the percentage of subjects that selected each category is presented.

Outcome measures

Outcome measures
Measure	Juvederm(R) Ultra Injectable Gel With Lidocaine n=32 Participants	Restylane(R) Injectable Gel
Comparative Pain Juvederm with Lidocaine less painful than Restylan	34 percent of participants	—
Comparative Pain Juvederm with Lidocaine slightly less painful than	50 percent of participants	—
Comparative Pain No difference	3 percent of participants	—
Comparative Pain Juvederm with Lidocaine slightly more painful than	9 percent of participants	—
Comparative Pain Juvederm with Lidocaine more painful than Restylan	3 percent of participants	—

SECONDARY outcome

Timeframe: Day 0, Day 14

Investigator determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF

Outcome measures

Outcome measures
Measure	Juvederm(R) Ultra Injectable Gel With Lidocaine n=32 Participants	Restylane(R) Injectable Gel n=32 Participants
Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity	1.4 units on a scale Standard Deviation 0.91	1.3 units on a scale Standard Deviation 0.90

SECONDARY outcome

Timeframe: Day 0, Day 14

Subject determination of improvement in NLF severity score on 5-point NLF Severity Scale (0 = None; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Extreme) two weeks after treatment with Juvéderm with Lidocaine in one NLF and Restylane in the other NLF

Outcome measures

Outcome measures
Measure	Juvederm(R) Ultra Injectable Gel With Lidocaine n=32 Participants	Restylane(R) Injectable Gel n=32 Participants
Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity	1.5 units on a scale Standard Deviation 0.88	1.4 units on a scale Standard Deviation 0.84

Adverse Events

Juvederm Ultra Injectable Gel With Lidocaine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Restylane

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Juvederm Ultra Injectable Gel With Lidocaine n=32 participants at risk	Restylane n=32 participants at risk
General disorders Injection site swelling	3.1% 1/32 • Number of events 1	9.4% 3/32 • Number of events 3
General disorders Injection site pain	3.1% 1/32 • Number of events 1	9.4% 3/32 • Number of events 3
General disorders Injection site induration	0.00% 0/32	6.2% 2/32 • Number of events 2

Additional Information

Steven P. James, MD, VP, Global Medical Affairs

Allergan, Inc.

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER