Extension Study for 43USSA1705
Not Applicable
Completed
- Conditions
- Nasolabial Folds
- Interventions
- Device: Sculptra Aesthetic 8 ml and Lidocaine
- Registration Number
- NCT04225273
- Lead Sponsor
- Galderma R&D
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705
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Exclusion Criteria
- Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
- Other condition preventing the subject from entering the study in the Investigator's opinion
- Participation in any interventional clinical study throughout the duration of the study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigational Arm in pivotal study- 43USSA1705 Sculptra Aesthetic 8 ml and Lidocaine Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection
- Primary Outcome Measures
Name Time Method Subject satisfaction score using a 5-point subject satisfaction questionnaire Weeks 72 and 96 after Baseline Responder rate using the Global Aesthetic Improvement Scale (GAIS) Weeks 72 and 96 after Baseline FACE-Q Appraisal of Lines: Nasolabial Folds Questionnaire Weeks 72 and 96 after Baseline Incidence of adverse events collected throughout the study period Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 Duration of adverse events collected throughout the study period Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 Time to onset of adverse events collected throughout the study period Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 Change from baseline on both sides of the face as assessed by the Evaluator using the Wrinkle Assessment Scale (WAS) Weeks 72 and 96 after Baseline Intensity of adverse events collected throughout the study period Baseline (initial treatment in pivotal study 43USSA1705) to Week 96
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Galderma Study Site
🇺🇸Spring, Texas, United States