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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)

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ClinicalTrials.gov Identifier: NCT00417469
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Wrinkles Device: NADGL Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Actual Study Completion Date : February 2007
Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. To evaluate the safety of NADGL.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417469


Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00417469     History of Changes
Other Study ID Numbers: NADGL00106
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015