Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Study Overview
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Brief Summary
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This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

Official Title
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A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Conditions
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Nasolabial Folds

Intervention / Treatment
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* Device: Sculptra Aesthetic 8ml
* Device: Sculptra Aesthetic 5ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion. Exclusion Criteria: Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit. Collagen, Hyaluronic Acid- 12 months Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

Ages Eligible for Study
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Minimum Age: 22 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 |
| --- | --- |
| Experimental: Investigational Study Product<br>Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) | Device: Sculptra Aesthetic 8ml<br>* Treatment of nasolabial folds<br>|
| Active Comparator: Reference Product<br>Injection with Sculptra Aesthetic reconstituted with 5ml SWFI | Device: Sculptra Aesthetic 5ml<br>* Treatment of nasolabial folds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkle Assessment Scale (WAS) Score | The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks | Weeks 16, 24, 32, and 40 | 
| Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment | Responders defined as at least improved (improved, much improved, very much improved) as assessed by the subject | Weeks 16, 24, 32, 40, and 48. | 
| Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment | Responders defined as at least improved (improved, much improved, very much improved) as assessed by the Treating Investigator | Weeks 16, 24, 32, 40 and 48 | 
| FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire | Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction | Baseline and at weeks 24, 32, 40 and 48 | 
| Satisfaction With Treatment: Does the Treatment Make You Look Younger? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject 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: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? | A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? | A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Would You do the Treatment Again? | A subject satisfaction question with responses Yes or No. | Week 16, 24, 32, 40 and 48 | 
| Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? | A subject satisfaction question with responses Yes or No. | Week 16, 24, 32, 40 and 48 | 
| Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting | Subjects were asked to complete the following questions in the subject diary: Did you feel comfortable to return to social engagement today? (Yes or No) If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time [using 24-hour clock]) | time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12 |