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.

This study has been completed.

First Received: February 16, 2006 Last Updated: May 1, 2009 History of Changes

Sponsors and Collaborators:	Genzyme Inamed Aesthetics
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00293163

Purpose

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.

Condition	Intervention	Phase
Facial Wrinkles	Device: Hylaform, Hylaform Plus (hylan B gel)	Phase IV

MedlinePlus related topics: Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study

Further study details as provided by Genzyme:

Primary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293163

Locations

United States, California
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States, 90036
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Pennsylvania
Society Hill Dermatology
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Genzyme

Inamed Aesthetics

Investigators

Study Director:

Patricia Walker, M.D.

Inamed Aesthetics

More Information

No publications provided

Study ID Numbers:	HYLA00204
Study First Received:	February 16, 2006
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00293163 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on May 07, 2009