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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Facial Wrinkles | Device: NADGL | Phase 3 |
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 |
- 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).
- To evaluate the safety of NADGL.

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

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
United States, Alabama | |
Birmingham, Alabama, United States, 35205 |
Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
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 |