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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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

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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.

Conditions

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Radiesse® Mixed with Lidocaine

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).

Group Type EXPERIMENTAL

Radiesse® Injectable Dermal Filler Mixed with Lidocaine

Intervention Type DEVICE

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)

Radiesse® without Lidocaine

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.

Group Type ACTIVE_COMPARATOR

Radiesse® Injectable Dermal Filler without Lidocaine

Intervention Type DEVICE

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)

Interventions

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Radiesse® Injectable Dermal Filler Mixed with Lidocaine

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)

Intervention Type DEVICE

Radiesse® Injectable Dermal Filler without Lidocaine

Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes