Trial Outcomes & Findings for Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE® (NCT NCT00929071)

Results Overview

Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

immediate post-injection

Results posted on

2014-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of the Addition of 0.3% Lidocaine With EVOLENCE®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pain Assessment n=10 Participants Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Age, Continuous	63.2 years STANDARD_DEVIATION 9.4 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: immediate post-injection

Subjects assessment of immediate post-injection pain severity using a visual analogue scale (VAS) 100 mm in length, ranging from no pain (0) to unbearable pain (100).

Outcome measures

Outcome measures
Measure	Pain Assessment for Evolence/Topical Anesthetic n=10 nasolabial folds Assess injection pain of Evolence/topical anesthetic left nasolabial fold collagen: Injectable collagen topical anesthetic	Pain Assessment for Evolence/Lidocaine n=10 nasolabial folds Assess injection pain of Evolence/Lidocaine right nasolabial fold collagen: Injectable collagen Lidocaine: admix anesthetic
Assessment of Immediate Post-injection Pain Severity by Subject	6.3 units on a scale Standard Deviation 2.0	2.0 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: immediate post injection

Investigators assessment of immediate post-injection pain severity using Thermometer Pain Scale (TPS) with a range of 0-10 where 0=no pain and 10=worst possible pain

Outcome measures

Outcome measures
Measure	Pain Assessment for Evolence/Topical Anesthetic n=10 nasolabial folds Assess injection pain of Evolence/topical anesthetic left nasolabial fold collagen: Injectable collagen topical anesthetic	Pain Assessment for Evolence/Lidocaine n=10 nasolabial folds Assess injection pain of Evolence/Lidocaine right nasolabial fold collagen: Injectable collagen Lidocaine: admix anesthetic
Assessment of Immediate Post-injection Pain Severity by Investigator	5.2 units on a scale Standard Deviation 2.1	2.0 units on a scale Standard Deviation 0.8

Adverse Events

Pain Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan H. Weinkle, MD

Phone: 941-794-5432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place