Trial Outcomes & Findings for Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds (NCT NCT00797459)

NCT ID: NCT00797459

Last Updated: 2013-09-06

Results Overview

No pain is noted at 0 mm and worst pain is noted at 100 mm.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

After Injection on Day of Treatment

Results posted on

2013-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Restylane Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Restylane n=60 Participants Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	52.1 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: After Injection on Day of Treatment

Population: This is a split-face design. Restylane and Restylane with Lidocaine was injected to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face had less pain, as measured by the Visual Analogue Scale (VAS).

No pain is noted at 0 mm and worst pain is noted at 100 mm.

Outcome measures

Outcome measures
Measure	Restylane n=100 Scores on a Scale Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.	Restylane-L n=100 Scores on a Scale Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
Treatment Difference in Pain as Measured by a Visual Analogue Scale	44.9 Scores on a VAS Scale Standard Deviation 31.5	14.7 Scores on a VAS Scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: 14 days after treatment when compared to baseline

This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.

Outcome measures

Outcome measures
Measure	Restylane n=60 Participants Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.	Restylane-L n=60 Participants Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
Wrinkle Improvement at Day 14	60 participants	59 participants

Adverse Events

Restylane-L Side of Face

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Restylane Side of Face

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Restylane-L Side of Face n=60 participants at risk Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).	Restylane Side of Face n=60 participants at risk The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
Vascular disorders Ecchymosis	38.3% 23/60 • Number of events 23	31.7% 19/60 • Number of events 19
General disorders Edema	40.0% 24/60 • Number of events 24	36.7% 22/60 • Number of events 22
General disorders Erythema	46.7% 28/60 • Number of events 28	45.0% 27/60 • Number of events 27
General disorders Tenderness	38.3% 23/60 • Number of events 23	43.3% 26/60 • Number of events 26
General disorders Pain	28.3% 17/60 • Number of events 17	30.0% 18/60 • Number of events 18
General disorders Pruitis	10.0% 6/60 • Number of events 6	6.7% 4/60 • Number of events 4
General disorders Papule	1.7% 1/60 • Number of events 1	3.3% 2/60 • Number of events 2
General disorders Vasospasm	1.7% 1/60 • Number of events 1	0.00% 0/60

Additional Information

Ron Staugaard

Medicis

Phone: 480-291-5652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60