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

• ClinicalTrials.gov Identifier: NCT00797459
• Recruitment Status: Completed
• First Posted: November 25, 2008
• Results First Posted: February 21, 2011
• Last Update Posted: September 6, 2013
• Sponsor: Medicis Global Service Corporation
• Collaborator: Q-Med Scandinavia, Inc.
• Information provided by (Responsible Party): Medicis Global Service Corporation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Nasolabial Folds	Device: Restylane and Restylane-L	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, 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
• Study Start Date: November 2008
• Actual Primary Completion Date: January 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Wrinkle Improvement at Day 14 [ Time Frame: 14 days after treatment when compared to baseline ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Medicis Global Service Corporation
• ClinicalTrials.gov Identifier: NCT00797459
• Other Study ID Numbers: MA-1100-001
• First Posted: November 25, 2008
• Results First Posted: February 21, 2011
• Last Update Posted: September 6, 2013
• Last Verified: August 2013

Keywords provided by Medicis Global Service Corporation:

Correction of Nasolabial Folds

Additional relevant MeSH terms:

Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents