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

This study has been completed.
Sponsor:
Collaborator:
Cosmeta Corp, A Gel-Del Technologies Company
Information provided by:
Cosmeta
ClinicalTrials.gov Identifier:
NCT00414544
First received: December 20, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Facial Wrinkles
Device: CosmetaLife
Device: Restylane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds

Further study details as provided by Cosmeta:

Primary Outcome Measures:
  • Change in Wrinkle Severity Rating Scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months [ Time Frame: 3, 9 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: October 2006
Study Completion Date: March 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: CosmetaLife
Dermal filler
Active Comparator: 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.
Device: Restylane
Dermal filler

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414544

Locations
United States, California
Beauty Renewed
Tracy, California, United States, 95376
United States, Georgia
North Atlantic Plastic and Reconstructive Surgery
Roswell, Georgia, United States, 30076
United States, Massachusetts
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Cosmetic Care Center, LLC
Edina, Minnesota, United States, 55424
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
Sponsors and Collaborators
Cosmeta
Cosmeta Corp, A Gel-Del Technologies Company
Investigators
Study Director: David B. Masters, Ph.D. Cosmeta™ Corp
  More Information

No publications provided

Responsible Party: David B. Masters/President, Cosmeta Corp, A Gel-Del Technologies Company
ClinicalTrials.gov Identifier: NCT00414544     History of Changes
Other Study ID Numbers: CosmetaLife 1
Study First Received: December 20, 2006
Results First Received: March 4, 2011
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Cosmeta:
Nasolabial folds
Dermal filler
Injectable dermal filler
Soft tissue augmentation

ClinicalTrials.gov processed this record on April 16, 2014