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

Medicis Global Service

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: Restylane and Restylane-L

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797459

MA-1100-001

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 1 patient group

Restylane and Restylane with Lidocaine

Experimental group

Description:

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.

Treatment:

Device: Restylane and Restylane-L