Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

Phase 2

Completed

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

• Registration Number: NCT00414544
• Lead Sponsor: Cosmeta

Brief Summary

This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Detailed Description

Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2007-09
• Study Completion: 2008-03
• Results First Submitted: 2011-03-04
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-08
• Results First Posted: 2011-06-10
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Patients 18 years of age or older
2. Patients with moderate nasolabial folds (3-4 WSRS scale)
3. Patients willing to provide written informed consent for their participation in the study
4. Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit

Exclusion Criteria

1. Patients with any aesthetic facial therapy within 6 months prior to
2. Patients with an any reaction to the skin test
3. Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
4. Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
5. Patients with an active infection of any kind, skin disease, connective tissue disorder
6. Patients who are pregnant or lactating
7. Patients enrolled in another investigational clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CosmetaLife	CosmetaLife	Test Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.
Restylane	Restylane	Control Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.

Primary Outcome Measures

Name	Time	Method
Change in Wrinkle Severity Rating Scale	baseline and 6 months	To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
Adverse Event Reporting	6 months

Secondary Outcome Measures

Name	Time	Method
Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months	3, 9 and 12 months

Trial Locations

Locations (5)

SkinCare Physicians of Chestnut Hill; 🇺🇸 Chestnut Hill, Massachusetts, United States

Beauty Renewed; 🇺🇸 Tracy, California, United States

Cosmetic Care Center, LLC; 🇺🇸 Edina, Minnesota, United States

North Atlantic Plastic and Reconstructive Surgery; 🇺🇸 Roswell, Georgia, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States