Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles

Not Applicable

Completed

Conditions: Cheek Wrinkles

Interventions: Device: Sculptra Aesthetic new dilution

Registration Number: NCT04124692

Lead Sponsor: Galderma R&D

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 149

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group: Sculptra Aesthetic	Sculptra Aesthetic new dilution	Participants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)

Primary Outcome Measures

Name	Time	Method
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12	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.

Secondary Outcome Measures

Name	Time	Method
Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Subject Satisfaction: Would You do the Treatment Again?	At Month 12	A subject satisfaction question with responses Yes or No.
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9	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.
Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment	At Months 7, 9, and 12	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.
Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12	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.
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	At Months 7, 9, and 12	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.
Satisfaction With Treatment: Does the Treatment Make You Look Younger?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment	At Month 12	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.
Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Excellent, Very good, Good, Satisfactory, Not satisfied.
Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?	At Months 7, 9, and 12	A 5-point subject satisfaction questionnaire with the following responses: Strongly agree, Agree, Neither agree or Disagree, Disagree, Strongly disagree.
Subject Satisfaction: Would You Recommend the Treatment to a Friend?	At Month 12	A subject satisfaction question with responses Yes or No.
Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores	Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	From start of study drug administration up to end of the study (up to Month 12)	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.