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

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

Completed

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Key information

Conditions

Facial Wrinkles

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hylaform, Hylaform Plus (hylan B gel)

Device

Primary outcomes

Non-inferiority as compared to standard of care as assigned by blinded reviewer.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Important dates

Study start: 2002
Study completion: 2003
First posted: Feb 8, 2006
Registry last updated: Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed