At a glance
ClinicalIndex Comparison RecordN/ACompleted· 111 enrolled
Drug / intervention
Sculptra Aethestic reconsituted with 8ml Sterile Water for Injectiondevice
Likely dose
Sculptra Aethestic reconsituted with 8ml Sterile Water for Injectionfrom 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 for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)
In Brief
A clinical study evaluating Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection for Cheek and Wrinkle. Completed, enrolled 111 participants across 13 sites.
Detailed Summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
Study Details
Timeline
N/ACompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedOct 2020
Primary CompletionJul 2022
TodayJul 2026
First PostedOct 20, 2020
Enrollment StartNov 12, 2019
Primary CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.7 years ago
Interventions
Sculptra Aethestic reconsituted with 8ml Sterile Water for Injectiondevice
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles