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

Nasolabial Folds Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797459
• Other study ID #: MA-1100-001
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: August 20, 2013
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2013
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

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.

Locations

Country	Name	City	State
United States	Dermatology Research Institute LLC	Coral Gables	Florida
United States	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland
United States	The Center for Dermatology, Cosmetic and Laser Surgery	Mount Kisco	New York

Sponsors (2)

Lead Sponsor	Collaborator
Medicis Global Service Corporation	Q-Med Scandinavia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No