CompletedPhase 2

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

United States145 participantsStarted 2006-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change in Wrinkle Severity Rating Scale

Timeframe: baseline and 6 months

Adverse Event Reporting

Timeframe: 6 months

Trial details

NCT IDNCT00414544

SponsorCosmeta

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-09

Results submitted2011-03-04

View on ClinicalTrials.gov More Facial Wrinkles trials