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

Not Applicable

Completed

• Conditions: Nasolabial Folds
• Interventions: Device: Restylane and Restylane-L

• Registration Number: NCT00797459
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Results First Submitted: 2010-08-11
• Results First Submitted QC: 2011-01-24
• Results First Posted: 2011-02-21
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Restylane and Restylane with Lidocaine	Restylane and Restylane-L	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Wrinkle Improvement at Day 14	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.

Trial Locations

Locations (3)

Maryland Laser Skin and Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Dermatology Research Institute LLC; 🇺🇸 Coral Gables, Florida, United States

The Center for Dermatology, Cosmetic and Laser Surgery; 🇺🇸 Mount Kisco, New York, United States