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
Name Time Method 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
Name Time Method
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