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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Treatment of nasolabial folds
Treatment of nasolabial folds
Galderma Study Site
Scottsdale, Arizona, United States
Galderma Study Site
Solana Beach, California, United States
Galderma Study Site
Bradenton, Florida, United States
Galderma Study Site
Austin, Texas, United States
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.
Time frame: 48 weeks
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
Time frame: 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
Time frame: 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
Time frame: Weeks 16, 24, 32, 40 and 48
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
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Galderma Study Site
Spring, Texas, United States
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 frame: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12