Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: February 7, 2006
Last updated: March 17, 2015
Last verified: March 2015
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

Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00288470

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

Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00288470     History of Changes
Other Study ID Numbers: HYLA-001-01 
Study First Received: February 7, 2006
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 25, 2016