PREVELLE Shape (CX002) Dermal Filler Protocol

Phase 3

Completed

• Conditions: Correction of Nasolabial Folds and Lip Augmentation
• Interventions: Device: PREVELLE Shape; Device: Restylane

• Registration Number: NCT00764257
• Lead Sponsor: Mentor Worldwide, LLC

Brief Summary

The purpose of this study was to assess PREVELLE Shape (CX002), with respect to safety and efficacy for one year following treatment, for correction of facial nasolabial folds and when applied as an intradermal implant for lip augmentation.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-19
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PREVELLE Shape	PREVELLE Shape	-
Restylane	Restylane	-

Primary Outcome Measures

Name	Time	Method
Study the safety and efficacy of CX002 when applied to the NLFs or lips.	1 year	The primary aim of the study is to assess CX002, with respect to safety and efficacy during the six months following treatment, in two subject cohorts: 1. When applied as an intradermal implant for the correction of facial nasolabial folds (Nasolabial Fold Cohort). Nasolabial folds were chosen as the fold/wrinkle for treatment as they are often the most severe facial wrinkles, representing a "worst-case" scenario; 2. When applied as an intradermal implant for lip augmentation (Lip Augmentation Cohort)

Trial Locations

Locations (1)

Mentor Worldwide, LLC; 🇺🇸 Santa Barbara, California, United States