Open Label Extension for 43USSA1812

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)

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 Overview

• Status: Completed
• Conditions: Wrinkle; Cheek
• Intervention / Treatment: Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Galderma Research Site
  • California
    • Encino, California, United States, 91436
      • Galderma Research Site
    • Redondo Beach, California, United States, 90277
      • Galderma Research Site
    • San Diego, California, United States, 92121
      • Galderma Research Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Galderma Research Site
  • Florida
    • Coral Gables, Florida, United States, 33143
      • Galderma Research Site
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Galderma Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Galderma Research Site
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Galderma Research Site
  • New York
    • New York, New York, United States, 10028
      • Galderma Research Site
    • New York, New York, United States, 10021
      • Galderma Research Site
  • Texas
    • Dallas, Texas, United States, 75254
      • Galderma Research Site
    • Spring, Texas, United States, 77388
      • Galderma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject completed Month 12 of study 43USSA1812
2. Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.

Exclusion Criteria:

1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Treatment Group in pivotal study; followed for long-term safety and effectiveness with no additional treatment
EXPERIMENTAL: Control Group in the pivotal study; receiving treatment in the extension study	Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection; Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles	A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently	Month 19
Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles	A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently	Month 21
Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles	A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently	Month 24

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2020
• Primary Completion (ACTUAL): July 20, 2022
• Study Completion (ACTUAL): July 20, 2022

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 43USSA1812ext

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes