Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Not Applicable

Completed

• Conditions: Nasolabial Folds
• Interventions: Device: Radiesse® Injectable Dermal Filler without Lidocaine; Device: Radiesse® Injectable Dermal Filler with Lidocaine

• Registration Number: NCT01069354
• Lead Sponsor: Merz North America, Inc.

Brief Summary

To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine

Detailed Description

To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold

Study Timeline

• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-15
• Study First Posted: 2010-02-17
• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2014-02
• Results First Submitted: 2016-09-08
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-18
• Last Update Submitted: 2017-09-18
• Results First Posted: 2018-05-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Is at least 18 years of age
• Is a candidate for nasolabial fold treatment using Radiesse
• Has approximately symmetrical nasolabial folds
• Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month

Exclusion Criteria

• Has received any type of treatment or procedures including surgery in the nasolabial folds
• Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
• Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face
• Has nasolabial folds that are too severe to be corrected in one treatment session
• Has any history of hypersensitivity to lidocaine or anesthetics of the amide type

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiesse® without Lidocaine	Radiesse® Injectable Dermal Filler without Lidocaine	Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
Radiesse® Mixed with Lidocaine	Radiesse® Injectable Dermal Filler with Lidocaine	Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Primary Outcome Measures

Name	Time	Method
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)	Immediately after injection (Time 0)	Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain).; In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection	4 weeks post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection	30 minutes post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection	45 minutes post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection	60 minutes post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection	1 week post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Assess Subject Preference to Pain	Immediately after injection (Time 0)	2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?; Only those participants responding "yes" to these 2 questions about pain and preference for treatment are reported in the table below.
Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection	15 minutes post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection	2 weeks post injection	A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS	Immediately after injection (Time 0)	In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm "reduction" (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF.