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

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

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

Study Overview

• Status: Completed
• Conditions: Nasolabial Folds
• Intervention / Treatment: Device: Restylane and Restylane-L

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Dermatology Research Institute LLC
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Laser Skin and Vein Institute
  • New York
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetic and Laser Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Difference in Pain as Measured by a Visual Analogue Scale	No pain is noted at 0 mm and worst pain is noted at 100 mm.	After Injection on Day of Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Improvement at Day 14	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.	14 days after treatment when compared to baseline

Collaborators and Investigators

• Sponsor: Medicis Global Service Corporation
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: November 24, 2008
• First Submitted That Met QC Criteria: November 24, 2008
• First Posted (Estimate): November 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 6, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Correction of Nasolabial Folds
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: MA-1100-001