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): 111
• 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

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 Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Sculptra Aesthetic; Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection	Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection; Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
Experimental: Group B: No Treatment; Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection.	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 Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest	Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on as scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.	At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic	Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles on a scale of 0 to 4. Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to rate their aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment.	At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment	GAIS responder rates are based on independent assessments by the investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the investigator to rate aesthetic improvement of the cheek wrinkles on a scale from "Very Much Improved" to "Very Much Worse" in a live assessment.	At Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look Younger?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?	A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You Recommend the Treatment to a Friend?	A subject satisfaction question with responses Yes or No.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Subject Satisfaction: Would You do the Treatment Again?	A subject satisfaction question with responses Yes or No.	At Months 19, 21, and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores	The participant assessed satisfaction using the 5 questions on the FACE-Q: Satisfaction with Cheeks Appearance questionnaire measured on a 4-point scale. The responses to the items were converted to a 100-point Rasch transformed total score with 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A negative change from baseline indicates less improvement.	Baseline, Months 19, 21 and 24 (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important. medical event. TEAEs included both serious and non-serious TEAEs.	From start of study drug administration up to end of the study (up to Month 24) (4 weeks is defined as one month in the study / study follow up windows for certain visits were +/- 2 weeks)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• 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): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

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