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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.
Inamed Aesthetics
Information provided by:
Sanofi Identifier:
First received: February 16, 2006
Last updated: March 4, 2015
Last verified: March 2015
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Sanofi:

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
Study Completion Date: October 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00293163

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, a Sanofi Company
Inamed Aesthetics
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Medical Monitor, Genzyme Corporation Identifier: NCT00293163     History of Changes
Other Study ID Numbers: HYLA00204
Study First Received: February 16, 2006
Last Updated: March 4, 2015 processed this record on September 19, 2017