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. - Full Text View

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 is ongoing, but not recruiting participants.

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

Study ID Numbers:	HYLA00204
First Received:	February 16, 2006
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00293163
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Facies

ClinicalTrials.gov processed this record on September 05, 2008