Status:
COMPLETED
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
Lead Sponsor:
Medicis Global Service Corporation
Collaborating Sponsors:
Q-Med Scandinavia, Inc.
Conditions:
Nasolabial Folds
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
Detailed Description
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which produc...
Eligibility Criteria
Inclusion
- Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate \[3\] or both Severe \[4\])
Exclusion
- Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
- Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
- Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
- Permanent implant placed in the Nasolabial Fold area
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00823069
Start Date
January 1 2009
End Date
April 1 2009
Last Update
November 30 2010
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Coral Gables, Florida, United States
2
Hunt Valley, Maryland, United States
3
Mount Cisco, New York, United States