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

This study has been completed.
Sponsor:
Collaborator:
Q-Med Scandinavia, Inc.
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT00797459
First received: November 24, 2008
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Nasolabial Folds
Device: Restylane and Restylane-L

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • Treatment Difference in Pain as Measured by a Visual Analogue Scale [ Time Frame: After Injection on Day of Treatment ] [ Designated as safety issue: No ]
    No pain is noted at 0 mm and worst pain is noted at 100 mm.


Secondary Outcome Measures:
  • Wrinkle Improvement at Day 14 [ Time Frame: 14 days after treatment when compared to baseline ] [ Designated as safety issue: No ]
    This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.


Enrollment: 60
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Restylane and Restylane with Lidocaine
This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive.
Device: Restylane and Restylane-L
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797459

Locations
United States, Florida
Dermatology Research Institute LLC
Coral Gables, Florida, United States, 33146
United States, Maryland
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, New York
The Center for Dermatology, Cosmetic and Laser Surgery
Mount Kisco, New York, United States, 10549
Sponsors and Collaborators
Medicis Global Service Corporation
Q-Med Scandinavia, Inc.
Investigators
Principal Investigator: David Bank, MD The Center for Dermatology, Cosmetic and Laser Surgery
Principal Investigator: Fredric Brandt, MD Dermatology Research Institute LLC
Principal Investigator: Robert Weiss, MD Maryland Laser Skin and Vein Institute
Study Director: Ron Staugaard Medicis Pharmaceutical
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT00797459     History of Changes
Other Study ID Numbers: MA-1100-001
Study First Received: November 24, 2008
Results First Received: August 11, 2010
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicis Global Service Corporation:
Correction of Nasolabial Folds

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014