Clinical trial NCT00414544: Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
Official title: A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Wrinkles
Keywords: Nasolabial folds
Dermal filler
Injectable dermal filler
Soft tissue augmentation
Lead sponsor: Cosmeta
Sponsor class: INDUSTRY
Collaborators: name: Cosmeta Corp, A Gel-Del Technologies Company
First posted: 2006-12-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Wrinkle Severity Rating Scale
timeFrame: baseline and 6 months
measure: Adverse Event Reporting
timeFrame: 6 months
Secondary outcomes:
measure: Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
timeFrame: 3, 9 and 12 months
Other outcomes:
Locations:
city: Tracy
country: United States
facility: Beauty Renewed
state: California
city: Roswell
country: United States
facility: North Atlantic Plastic and Reconstructive Surgery
state: Georgia
city: Chestnut Hill
country: United States
facility: SkinCare Physicians of Chestnut Hill
state: Massachusetts
city: Edina
country: United States
facility: Cosmetic Care Center, LLC
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
Study officials:
affiliation: Cosmeta™ Corp
name: David B. Masters, Ph.D.
role: STUDY_DIRECTOR
References: