At a glance
ClinicalIndex Comparison RecordN/ACompleted· 38 enrolled
Drug / intervention
Sculptra Aesthetic, Lidocaine HCLdevice
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.
Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)
In Brief
A clinical study evaluating Sculptra Aesthetic, Lidocaine HCL for Nasolabial Folds. Completed, enrolled 38 participants across 4 sites.
Detailed Summary
To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolabial Folds
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedJan 2020
Primary CompletionJan 2021
TodayJul 2026
First PostedJan 13, 2020
Enrollment StartDec 3, 2019
Primary CompletionJan 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.5 years ago
Interventions
Sculptra Aesthetic, Lidocaine HCLdevice
No intervention was administered during this extension study.