HYLA-001-01: A Double-Blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00288470

Purpose

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

Condition	Intervention	Phase
Facial Wrinkles	Device: Hylaform, Hylaform Plus (hylan B gel)	N/A

Study Type: Interventional
Study Design: Treatment
Further Study Details:
Primary Non-inferiority as compared to standard of care as assigned by blinded reviewer.
Study Start: 2002-06; Study Completion: 2003-08

Eligibility

Ages Eligible for Study: 30 Years - 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 over-the-counter products

Location Information

More Information

Study ID Numbers HYLA-001-01
NLM Identifier NCT00288470
Health Authority: United States: Food and Drug Administration