Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069354
• Other study ID #: P120677
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2017
• Source: Merz North America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Radiesse® Injectable Dermal Filler with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)
• Radiesse® Injectable Dermal Filler without Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz North America, Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)