At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 145 enrolled
Drug / intervention
CosmetaLife +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds
In Brief
A Phase 2 clinical trial evaluating CosmetaLife and Restylane for Facial Wrinkles. Completed, enrolled 145 participants across 5 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Wrinkles
CountriesUnited States
CollaboratorsCosmeta Corp, A Gel-Del Technologies Company
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2006
First PostedDec 2006
Primary CompletionSep 2007
Study CompletionMar 2008
TodayJul 2026
First PostedDec 21, 2006
Enrollment StartOct 1, 2006
Primary CompletionSep 1, 2007
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.5 years ago
Interventions
CosmetaLifedevice
Dermal filler
Restylanedevice
Dermal filler