Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Study Overview
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Brief Summary
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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.

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

Conditions
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Cheek Wrinkles

Intervention / Treatment
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* Device: Sculptra Aesthetic new dilution


Participation Criteria
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Eligibility Criteria
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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: Collagen, Hyaluronic Acid - 12 months Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group: No-treatment<br>Participants will receive no treatment during the study. | |
| Experimental: Treatment Group: Sculptra Aesthetic<br>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<br>* Treatment of cheek wrinkles<br>|

What is the study measuring?
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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) |