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

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ClinicalTrials.gov Identifier: NCT00288470
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : March 18, 2015
Sponsor:
Information provided by:
Sanofi

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

Condition or disease Intervention/treatment Phase
Facial Wrinkles Device: Hylaform, Hylaform Plus (hylan B gel) Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : June 2002
Study Completion Date : August 2003



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


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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

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

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