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

Facial Wrinkles Clinical Trial

Official title:

A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414544
• Other study ID #: CosmetaLife 1
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2006
• Last updated: June 22, 2011
• Start date: October 2006
• Est. completion date: March 2008

Study information

• Verified date: June 2011
• Source: Cosmeta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

Device:
• CosmetaLife
Dermal filler
• Restylane
Dermal filler

Locations

Country	Name	City	State
United States	SkinCare Physicians of Chestnut Hill	Chestnut Hill	Massachusetts
United States	Cosmetic Care Center, LLC	Edina	Minnesota
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	North Atlantic Plastic and Reconstructive Surgery	Roswell	Georgia
United States	Beauty Renewed	Tracy	California

Sponsors (2)

Lead Sponsor	Collaborator
Cosmeta	Cosmeta Corp, A Gel-Del Technologies Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wrinkle Severity Rating Scale	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.	baseline and 6 months	No
Primary	Adverse Event Reporting		6 months	Yes
Secondary	Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months		3, 9 and 12 months	Yes