Phase 2
Completed N=145
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
Facial Wrinkles
Source: ClinicalTrials.gov NCT00414544 ↗
Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Change in Wrinkle Severity Rating Scale — -0.94; -1.07 units on scale
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).
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 |
— | — |
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. Informational only — not medical advice.