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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
GroupInterventionDescription
Investigational Arm in pivotal study- 43USSA1705Sculptra Aesthetic 8 ml and LidocaineInjection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection
Primary Outcome Measures
NameTimeMethod
Subject satisfaction score using a 5-point subject satisfaction questionnaireWeeks 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 QuestionnaireWeeks 72 and 96 after Baseline
Incidence of adverse events collected throughout the study periodBaseline (initial treatment in pivotal study 43USSA1705) to Week 96
Duration of adverse events collected throughout the study periodBaseline (initial treatment in pivotal study 43USSA1705) to Week 96
Time to onset of adverse events collected throughout the study periodBaseline (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 periodBaseline (initial treatment in pivotal study 43USSA1705) to Week 96
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Galderma Study Site

🇺🇸

Spring, Texas, United States

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