Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Study Overview
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Brief Summary
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To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine

Detailed Description
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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

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

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Radiesse® Injectable Dermal Filler with Lidocaine
* Device: Radiesse® Injectable Dermal Filler without Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiesse® Mixed with Lidocaine<br>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<br>* Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)<br>|
| Active Comparator: Radiesse® without Lidocaine<br>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<br>* Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate to severe wrinkles and folds such as nasolabial folds