A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique. - Tabular View

Tracking Information

First Received Date ^ICMJE

February 16, 2006

Last Updated Date

July 30, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

no difference in keloid and scar formation
pigmentation disorders
hypersensitivity reactions in patients with skin color compared to other patients when treated for wrinkle correction with Hylaform, Hylaform Plus or Captique

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00293163 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.

Official Title ^ICMJE

Brief Summary

To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Condition ^ICMJE

Facial Wrinkles

Intervention ^ICMJE

Device: Hylaform, Hylaform Plus (hylan B gel)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00293163

Responsible Party

Medical Monitor, Genzyme Corporation

Study ID Numbers ^ICMJE

HYLA00204

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Inamed Aesthetics

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP