Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds

Not Applicable

Completed

• Conditions: Facial Wrinkles
• Interventions: Device: Aquamid; Device: Restylane

• Registration Number: NCT00407914
• Lead Sponsor: Contura

Brief Summary

The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.

The study includes an extended follow up to 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-04
• Study First Submitted QC: 2006-12-04
• Study First Posted: 2006-12-05
• Primary Completion: 2008-08
• Study Completion: 2009-07
• Disposition First Submitted: 2009-07-01
• Disposition First Submitted QC: 2009-07-01
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-06
• Disposition First Posted: 2009-10-08
• Last Update Posted: 2009-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

• interested on soft tissue augmentation for the nasolabial folds
• moderate to severe nasolabial fold

Exclusion Criteria

• sensitivity to anesthetics
• allergy to hyaluronic acid
• previous treatment with permanent fillers in the treated area
• recent previous aesthetic procedure in the treatment area
• infected skin areas or autoimmune diseases affecting the skin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Aquamid	Aquamid
2	Restylane	Restylane

Primary Outcome Measures

Name	Time	Method
Wrinkle Assessment Scale	Baseline, 3, 6, 9, 12 Months
Adverse device effects	continuosly

Secondary Outcome Measures

Name	Time	Method
Global Aesthetic Improvement Scale	Optimal treatment, 3, 6, 9 and 12 Months
Injection site reactions	After injection
Adverse events	continuosly