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, a Sanofi Company120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Facial Wrinkles

Interventions

Hylaform, Hylaform Plus (hylan B gel)DEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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