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Search / Trial NCT00797459

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 01, 2025

Completed

Keywords

Correction Of Nasolabial Folds

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.

Locations

Coral Gables, Florida, United States

Hunt Valley, Maryland, United States

Mount Kisco, New York, United States

Patients applied

0 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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