Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

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

Detailed Description
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To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed 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 Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Radiesse® Injectable Dermal Filler Mixed 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. Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month. Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements. Has approximately symmetrical nasolabial folds. Exclusion Criteria: Has received any type of treatment or procedures including surgery in the nasolabial folds. Has received neurotoxins in the lower half of the face in the past 6 months. Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years. 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 a history of chronic or recurrent infection or inflammation that would preclude participation in the study. Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding. Is female and of child bearing potential and is pregnant or not using acceptable method of birth control. Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type. Has a history of anaphylaxis or multiple severe allergies. Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.

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 50 participants received both the treatment device and the control device at the same time (left and right sides of face). | Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine<br>* Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)<br>|
| Active Comparator: Radiesse® without Lidocaine<br>Injectable Dermal Filler. The same 50 participants received both the treatment device and the control 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 2% 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 Pain Scale (1 = no Pain, 10 = Very Severe Pain) | Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain). | Immediately after injection (Time 0) | 
| Patients With Clinically Significant Reduction in Pain | Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain). | 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