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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:
ClinicalTrials.gov Identifier:
NCT00288470
First Posted: February 8, 2006
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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 Sanofi:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00288470


Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00288470     History of Changes
Other Study ID Numbers: HYLA-001-01
First Submitted: February 7, 2006
First Posted: February 8, 2006
Last Update Posted: March 18, 2015
Last Verified: March 2015