Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.

The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.

Study Overview

• Status: Completed
• Conditions: Cheek Wrinkles
• Intervention / Treatment: Device: Sculptra Aesthetic new dilution

• Study Type: Interventional
• Enrollment (Actual): 149
• 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: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion Criteria:

• Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

• Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

  1. Collagen, Hyaluronic Acid - 12 months
  2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group: No-treatment; Participants will receive no treatment during the study.
Experimental: Treatment Group: Sculptra Aesthetic; Participants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)	Device: Sculptra Aesthetic new dilution; 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 at Month 12	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.	At Months 7 and 9
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12	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: 0 (none [no lines or wrinkles]), 1 (mild [only few superficial lines]), 2 (moderate [many superficial lines or a few shallow wrinkles]), 3 (severe [many shallow wrinkles or a few moderate depth wrinkles]) and 4 (very severe [many moderate wrinkles or at least one depth wrinkle with or without redundant folds]). Higher score means more severe (worse) wrinkles. The participant was to have a closed maximum smile during the assessment.	At Months 7, 9, and 12
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment	Improvement rate based on the Independent Photographic Reviewer's assessment using random pairings of baseline and Month 12 photographs was done. An improved subject is defined as a subject for whom the Independent Photographic Reviewer identified the month 12 photograph in the pair as post-treatment.	At Month 12
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 live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.	At Months 7, 9, and 12
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 live assess the aesthetic improvement of the cheek wrinkles by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.	At Months 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.	At Months 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
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 7, 9, and 12
Subject Satisfaction: Would You Recommend the Treatment to a Friend?	A subject satisfaction question with responses Yes or No.	At Month 12
Subject Satisfaction: Would You do the Treatment Again?	A subject satisfaction question with responses Yes or No.	At Month 12
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 where 1=very dissatisfied, 2=somewhat dissatisfied, 3=somewhat satisfied, and 4=very satisfied. 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.	Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12
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 12)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 43USSA1812

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