Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
- Conditions
- Nasolabial Folds
- Interventions
- Device: Sculptra Aesthetic 8mlDevice: Sculptra Aesthetic 5ml
- Registration Number
- NCT03780244
- Lead Sponsor
- Galderma R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigational Study Product Sculptra Aesthetic 8ml Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI) Reference Product Sculptra Aesthetic 5ml Injection with Sculptra Aesthetic reconstituted with 5ml SWFI
- Primary Outcome Measures
Name Time Method Change in Wrinkle Assessment Scale (WAS) Score 48 weeks 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.
- Secondary Outcome Measures
Name Time Method Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Would You do the Treatment Again? Week 16, 24, 32, 40 and 48 A subject satisfaction question with responses Yes or No.
Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12 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 \[using 24-hour clock\])Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment Weeks 16, 24, 32, 40 and 48 Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator
Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Change in Wrinkle Assessment Scale (WAS) Score Weeks 16, 24, 32, and 40 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 weeksResponder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment Weeks 16, 24, 32, 40, and 48. Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject
FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire Baseline and at weeks 24, 32, 40 and 48 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
Satisfaction With Treatment: Does the Treatment Make You Look Younger? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.
Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? Week 16, 24, 32, 40 and 48 A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.
Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? Week 16, 24, 32, 40 and 48 A subject satisfaction question with responses Yes or No.
Trial Locations
- Locations (1)
Galderma Study Site
🇺🇸Spring, Texas, United States