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

An Open-label Study of the Safety of Restylane and Perlane in the Correction of Peri-oral Wrinkles.

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

Study Overview

• Status: Completed
• Conditions: Peri-oral Wrinkles
• Intervention / Treatment: Device: Restylane and Perlane

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
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  • Texas
    • Dallas, Texas, United States, 75254
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Restylane and Perlane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2-weeks

Collaborators and Investigators

• Sponsor: Medicis Global Service Corporation
• Investigators: Study Chair: Mary Sanstead, RN, BSN, CCRC, Medicis Global Services

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 14, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 10, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Correction of peri-oral wrinkles
• Other Study ID Numbers: MA-1900-01