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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Peri-oral Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restylane and Perlane

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.

Group Type ACTIVE_COMPARATOR

Restylane and Perlane

Intervention Type DEVICE

Interventions

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Restylane and Perlane

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No