Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-02-28

Brief Summary

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To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler 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 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 participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Group Type EXPERIMENTAL

Radiesse® Injectable Dermal Filler with Lidocaine

Intervention Type DEVICE

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

Radiesse® without Lidocaine

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).

Group Type ACTIVE_COMPARATOR

Radiesse® Injectable Dermal Filler without Lidocaine

Intervention Type DEVICE

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

Interventions

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Radiesse® Injectable Dermal Filler with Lidocaine

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

Intervention Type DEVICE

Radiesse® Injectable Dermal Filler without Lidocaine

Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes