A Double-blinded Evaluation of Safety and Efficacy of Hylaform and Hylaform Plus Compared to Zyplast.
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
A clinical study to investigate the safety and efficacy of Hylaform and Hylaform Plus for correction of facial wrinkles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2002
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
June 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 8, 2006
CompletedMarch 18, 2015
March 1, 2015
February 7, 2006
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Non-inferiority as compared to standard of care as assigned by blinded reviewer.
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 ovet-the-counter products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 8, 2006
Study Start
June 1, 2002
Study Completion
August 1, 2003
Last Updated
March 18, 2015
Record last verified: 2015-03