Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Launched by MEDICIS GLOBAL SERVICE CORPORATION · Nov 24, 2008
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Medicis Global Service Corporation
Medicis Global Service Corporation is a distinguished clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a strong commitment to improving patient outcomes, the organization specializes in conducting rigorous clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and state-of-the-art methodologies, Medicis Global Service Corporation ensures the highest standards of safety, efficacy, and ethical practice in all its studies. By fostering collaboration with healthcare providers and regulatory bodies, the company aims to bring groundbreaking therapies to market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Coral Gables, Florida, United States
Hunt Valley, Maryland, United States
Mount Kisco, New York, United States
Patients applied
Trial Officials
David Bank, MD
Principal Investigator
The Center for Dermatology, Cosmetic and Laser Surgery
Fredric Brandt, MD
Principal Investigator
Dermatology Research Institute LLC
Robert Weiss, MD
Principal Investigator
Maryland Laser Skin and Vein Institute
Ron Staugaard
Study Director
Medicis Pharmaceutical
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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