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

Phase 4

Completed

• Conditions: Peri-oral Wrinkles

• Registration Number: NCT00977704
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-14
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2011-12-22
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-07
• Last Update Submitted: 2013-05-07
• Results First Posted: 2013-06-10
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Local and Systemic Adverse Events	2-weeks	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)

Trial Locations

Locations (1)

Call For Information; 🇺🇸 Dallas, Texas, United States