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.

Genzyme

Status and phase: Completed; Phase 4

Conditions: Facial Wrinkles

Treatments: Device: Hylaform, Hylaform Plus (hylan B gel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293163

HYLA00204

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)