At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 enrolled
Drug / intervention
Sculptra Aesthetic 8ml +1 moredevice
Likely dose
Sculptra Aesthetic 8mlfrom 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, 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 8ml and Sculptra Aesthetic 5ml for Nasolabial Folds. Completed, enrolled 80 participants across 5 sites.
Detailed Summary
This study has been designed to evaluate the 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
20192020202120222023202420252026
Enrollment StartDec 2018
First PostedDec 2018
Primary CompletionFeb 2020
TodayJul 2026
First PostedDec 19, 2018
Enrollment StartDec 18, 2018
Primary CompletionFeb 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.5 years ago
Interventions
Sculptra Aesthetic 8mldevice
Treatment of nasolabial folds
Sculptra Aesthetic 5mldevice
Treatment of nasolabial folds