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

Medicis Global Service

Status: Completed

Conditions: Nasolabial Folds

Treatments: Device: Perlane and Perlane-L

Study type: Interventional

Funder types: Industry

Identifiers

NCT00823069

MA-1400-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 1 patient group

Perlane and Perlane-L

Other group

Description:

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.

Treatment:

Device: Perlane and Perlane-L