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

NCT01012661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-04-26

Study results available
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Summary

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

Conditions

  • Nasolabial Folds

Interventions

DEVICE

Radiesse® Injectable Dermal Filler Mixed with Lidocaine

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

DEVICE

Radiesse® Injectable Dermal Filler without Lidocaine

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

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012661 on ClinicalTrials.gov