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

Phase 4CompletedNCT00977704

Medicis Global Service Corporation20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peri-oral Wrinkles

Interventions

Restylane and PerlaneDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Call For Information

Coral Gables, Florida, United States

Call For Information

Dallas, Texas, United States

Outcomes

Primary Outcomes

Local and Systemic Adverse Events

To examine the safety of Restylane and Perlane when used in the treatment of facial wrinkles and folds by identification of the point incidence of: * All local adverse events as reported by healthcare professional * All systemic adverse events (related and unrelated)

Time frame: 2-weeks

Data from ClinicalTrials.gov

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