Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

Not Applicable

Completed

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

• Registration Number: NCT00823069
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.

Detailed Description

This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Primary Completion: 2009-03
• Study Completion: 2009-04
• Results First Submitted: 2010-08-25
• Status Verified: 2010-11
• Results First Submitted QC: 2010-11-01
• Last Update Submitted: 2010-11-01
• Results First Posted: 2010-11-30
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

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

Inclusion Criteria

• Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate [3] or both Severe [4])

Exclusion Criteria

• Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
• 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 Nasolabial Fold area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perlane and Perlane-L	Perlane and Perlane-L	This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive.

Primary Outcome Measures

Name	Time	Method
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm	After Injection on Day of Treatment

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Showing 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.