Skip to main content
OpenTrials
Completed

NCT Number: NCT04595331

Open Label Extension for 43USSA1812

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cheek Wrinkle

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Device

Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles

Primary outcomes

  1. Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest

    Time frame: 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)

    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.

Secondary outcomes

  1. Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic

    Time frame: 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)

    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.

  2. Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment

    Time frame: 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)

    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.

  3. Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment

    Time frame: 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)

    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.

  4. Satisfaction With Treatment: Does the Treatment Make You Look Younger?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  5. Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  6. Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  7. Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  8. Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  9. Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  10. Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  11. Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  12. Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  13. Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.

  14. Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.

  15. Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?

    Time frame: 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)

    A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither Agree or Disagree, Disagree, Strongly Disagree.

  16. Subject Satisfaction: Would You Recommend the Treatment to a Friend?

    Time frame: 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)

    A subject satisfaction question with responses Yes or No.

  17. Subject Satisfaction: Would You do the Treatment Again?

    Time frame: 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)

    A subject satisfaction question with responses Yes or No.

  18. Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores

    Time frame: 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)

    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.

  19. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2020
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.