A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)

March 4, 2015 updated by: Genzyme, a Sanofi Company

A Single-Blind, Randomized, Single-Center Evaluation of Procedural and Post Procedural Pain Experienced With Injections of NADG With Lidocaine Injectable Gel as Compared to Captique® Injectable Gel in Subjects Undergoing Cutaneous Correction of Nasolabial Folds

The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

45 subjects are planned; a portion of these subjects will have skin of color

Study Type

Interventional

Enrollment

45

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35205

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale.

Exclusion Criteria:

  • pregnant/lactating women
  • subjects who have an allergy to lidocaine or other amide-type anesthetics

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: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs).

Secondary Outcome Measures

Outcome Measure
To evaluate the safety of NADGL.

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

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

January 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (Estimate)

January 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • NADGL00106

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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