Trial Outcomes & Findings for Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose (NCT NCT00823069)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

After Injection on Day of Treatment

Results posted on

2010-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Perlane-L and Perlane Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Perlane and Perlane-L n=60 Participants Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
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	53.4 years STANDARD_DEVIATION 8.0 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	4 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. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.

Outcome measures

Outcome measures
Measure	Perlane-L and Perlane n=60 Participants Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.	Perlane Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm	95 Participants Interval 86.1 to 99.0	—

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	Perlane-L and Perlane n=60 Participants Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.	Perlane n=60 Participants Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
Number of Subjects Showing Wrinkle Improvement at Day 14	57 Participants	58 Participants

Adverse Events

Perlane-L

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Perlane

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Perlane-L n=60 participants at risk Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.	Perlane n=60 participants at risk Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
General disorders Bruising	60.0% 36/60 • Number of events 36	55.0% 33/60 • Number of events 33
General disorders Redness	56.7% 34/60 • Number of events 34	51.7% 31/60 • Number of events 31
General disorders Swelling	70.0% 42/60 • Number of events 42	65.0% 39/60 • Number of events 39
General disorders Pain	46.7% 28/60 • Number of events 28	43.3% 26/60 • Number of events 26
General disorders Tenderness	83.3% 50/60 • Number of events 50	81.7% 49/60 • Number of events 49
General disorders Itching	26.7% 16/60 • Number of events 16	20.0% 12/60 • Number of events 12

Additional Information

Mary Sanstead

Medicis

Phone: 480-291-5926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60