At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 100 enrolled
Drug / intervention
Radiesse® Injectable Dermal Fillerdevice
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.
Post-Marketing Study of Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds in Persons of Color
In Brief
A Phase 4 clinical trial evaluating Radiesse® Injectable Dermal Filler for Nasolabial Folds. Completed, enrolled 100 participants across 5 sites.
Detailed Summary
Post marketing study to assess the likelihood of hypertropic scarring, keloid formation and hyper- or hypopigmentation in patients with Fitzpatrick Skin Types IV, V, and VI receiving nasolabial fold treatment with Radiesse® Injectable Dermal Filler
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Folds
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
Primary CompletionDec 2007
Study CompletionFeb 2008
First PostedNov 2009
TodayJul 2026
First PostedNov 13, 2009
Enrollment StartMar 1, 2007
Primary CompletionDec 1, 2007
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.6 years ago
Interventions
Radiesse® Injectable Dermal Fillerdevice
Calcium hydroxylapatite particles suspected in an aqueous based gel carrier