Status:
COMPLETED
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
Lead Sponsor:
Cosmeta
Collaborating Sponsors:
Cosmeta Corp, A Gel-Del Technologies Company
Conditions:
Facial Wrinkles
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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....
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 desig...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- Patients with moderate nasolabial folds (3-4 WSRS scale)
- Patients willing to provide written informed consent for their participation in the study
- Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit
Exclusion
- Patients with any aesthetic facial therapy within 6 months prior to
- Patients with an any reaction to the skin test
- Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
- Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
- Patients with an active infection of any kind, skin disease, connective tissue disorder
- Patients who are pregnant or lactating
- Patients enrolled in another investigational clinical trial
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00414544
Start Date
October 1 2006
End Date
March 1 2008
Last Update
June 27 2011
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Beauty Renewed
Tracy, California, United States, 95376
2
North Atlantic Plastic and Reconstructive Surgery
Roswell, Georgia, United States, 30076
3
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
4
Cosmetic Care Center, LLC
Edina, Minnesota, United States, 55424