Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Merz North America, Inc.102 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Nasolabial Folds

Interventions

Radiesse® Injectable Dermal Filler with LidocaineDEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)

Radiesse® Injectable Dermal Filler without LidocaineDEVICE

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Toronto, Canada

Unnamed facility

Woodbridge, Canada

Outcomes

Primary Outcomes

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.

Time frame: Immediately after injection (Time 0)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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