A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.

Not Applicable

Completed

• Conditions: Facial Wrinkles

• Registration Number: NCT00288470
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study Completion: 2003-08
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria

• pregnant/lactating women
• patients who previously received permanent facial implants or using ovet-the-counter products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-inferiority as compared to standard of care as assigned by blinded reviewer.