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

April 19, 2013 updated by: Merz North America, Inc.

Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Rockville, Maryland, United States
    • New York
      • New York, New York, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
ACTIVE_COMPARATOR: 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.
Device: Radiesse® Injectable Dermal Filler without Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)

What is the study measuring?

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)
Time Frame: Immediately after injection (Time 0)
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
Time Frame: Immediately after injection (Time 0)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 12, 2009

First Posted (ESTIMATE)

November 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 19, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0408329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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