Phase 2
N=145
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
Facial Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT00414544 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Change in Wrinkle Severity Rating Scale — -0.94; -1.07 units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CosmetaLife (Device); Restylane (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cosmeta
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wrinkle Severity Rating Scale |
-0.94; -1.07 | — |
| PRIMARY Adverse Event Reporting |
— | — |
| SECONDARY Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months |
— | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00414544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.