Status:
COMPLETED
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
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 \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
Detailed Description
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Eligibility Criteria
Inclusion
- Subjects seeking augmentation therapy for correction of bilateral NLFs
- Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
- Subjects willing to give written informed consent to participate in the study
- Women of childbearing potential willing to use an acceptable form of birth control during the study period
Exclusion
- Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
- 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 NLF area
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00797459
Start Date
November 1 2008
End Date
March 1 2009
Last Update
September 6 2013
Active Locations (3)
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1
Dermatology Research Institute LLC
Coral Gables, Florida, United States, 33146
2
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
3
The Center for Dermatology, Cosmetic and Laser Surgery
Mount Kisco, New York, United States, 10549