Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds

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

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: Radiesse® Injectable Dermal Filler with Lidocaine; Device: Radiesse® Injectable Dermal Filler without 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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
  • Woodbridge, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiesse® Mixed 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).	Device: Radiesse® Injectable Dermal Filler with Lidocaine; Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)
Active Comparator: Radiesse® 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).	Device: Radiesse® Injectable Dermal Filler without Lidocaine; Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)	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.	Immediately after injection (Time 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS	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.	Immediately after injection (Time 0)
Visual Analogue Scale (VAS) Pain Score 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.	15 minutes post injection
Visual Analogue Scale (VAS) Pain Score 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.	30 minutes post injection
Visual Analogue Scale (VAS) Pain Score 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.	45 minutes post injection
Visual Analogue Scale (VAS) Pain Score 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.	60 minutes post injection
Visual Analogue Scale (VAS) Pain Score 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.	1 week post injection
Visual Analogue Scale (VAS) Pain Score 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.	2 weeks post injection
Visual Analogue Scale (VAS) Pain Score 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.	4 weeks post injection
Assess Subject Preference to Pain	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.	Immediately after injection (Time 0)

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Fred Derosier, DO, Merz North America, Inc.

Publications and helpful links

General Publications

• Schachter D, Bertucci V, Solish N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 15, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Moderate to severe wrinkles and folds such as nasolabial folds
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: P120677