Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

Completed · Not applicable

Conditions studied: Nasolabial Folds

In brief

Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

Key facts

Study ID

NCT00797459

Run by

Medicis Global Service Corporation

People needed

60

Starts

2008-11-01

Expected to finish

2009-03-01

Last updated by the study team

2013-09-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dermatology Research Institute LLC — Coral Gables, Florida, United States
• Maryland Laser Skin and Vein Institute — Hunt Valley, Maryland, United States
• The Center for Dermatology, Cosmetic and Laser Surgery — Mount Kisco, New York, United States

Full record on ClinicalTrials.gov

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