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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.

Phase 4
Completed
Conditions
Facial Wrinkles
Registration Number
NCT00293163
Lead Sponsor
Genzyme, a Sanofi Company
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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
Secondary Outcome Measures
NameTimeMethod

Trial Locations

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

Vitiligo & Pigmentation Institute of Southern California
🇺🇸Los Angeles, California, United States

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