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.

Completed · Phase 4

Conditions studied: Facial Wrinkles

In brief

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.

Key facts

Study ID

NCT00293163

Run by

Genzyme, a Sanofi Company

People needed

120

Starts

2006-02-01

Expected to finish

2006-10-01

Last updated by the study team

2015-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

You may not qualify if…

• pregnant/lactating women
• patients who previously received permanent facial implants or using over-the-counter products

Where it is running

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

Full record on ClinicalTrials.gov

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