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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.
Sponsor:
Collaborator:
Inamed Aesthetics
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00293163
First received: February 16, 2006
Last updated: July 30, 2009
Last verified: May 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00293163     History of Changes
Other Study ID Numbers: HYLA00204
Study First Received: February 16, 2006
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on June 18, 2013