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

Cosmeta Corp

Status and phase: Completed; Phase 2

Conditions: Facial Wrinkles

Treatments: Device: CosmetaLife; Device: Restylane

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00414544

CosmetaLife 1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups

CosmetaLife

Experimental group

Description:

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.

Treatment:

Device: CosmetaLife

Restylane

Active Comparator group

Description:

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.

Treatment:

Device: Restylane