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.
1 other identifier
interventional
120
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2006
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2006
CompletedFirst Posted
Study publicly available on registry
February 17, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedMarch 5, 2015
March 1, 2015
February 16, 2006
March 4, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genzyme, a Sanofi Companylead
- Inamed Aestheticscollaborator
Study Sites (3)
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, 90036, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107, United States
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2006
First Posted
February 17, 2006
Study Start
February 1, 2006
Study Completion
October 1, 2006
Last Updated
March 5, 2015
Record last verified: 2015-03