Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

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.

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.

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.

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

A subject satisfaction question with responses Yes or No.

A subject satisfaction question with responses Yes or No.

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.

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.