Study of Restylane and Perlane in the Correction of Peri-Oral Wrinkles

Medicis Global Service

Status and phase: Completed; Phase 4

Conditions: Peri-oral Wrinkles

Treatments: Device: Restylane and Perlane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00977704

MA-1900-01

Details and patient eligibility

About

This is an open-label study to assess safety using Restylane and Perlane in the correction of facial wrinkles.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Same Wrinkle Severity (either both Moderate [3] or both Severe [4]) of marionette lines and upper peri-oral rhytids

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Restylane and Perlane

Active Comparator group

Description:

Restylane and Perlane administered by injection. Recommended volume of 6.0 mL. Injection on study day 1 with an optional touch up on study day 14.

Treatment:

Device: Restylane and Perlane