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

This study has been completed.
Sponsor:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00288470
First received: February 7, 2006
Last updated: July 30, 2009
Last verified: February 2006
History of Changes
  Purpose

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


Condition Intervention
Facial Wrinkles
 Device: Hylaform, Hylaform Plus (hylan B gel)

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Genzyme:

Primary Outcome Measures:
  • Non-inferiority as compared to standard of care as assigned by blinded reviewer.

Study Start Date: June 2002
Estimated Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00288470

Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00288470     History of Changes
Other Study ID Numbers: HYLA-001-01
Study First Received: February 7, 2006
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013