NCT03780244CompletedNot Applicable
A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 80
- Locations
- 6
- Primary Endpoint
- Change in Wrinkle Assessment Scale (WAS) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change in Wrinkle Assessment Scale (WAS) Score
Time Frame: 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 Outcomes
- Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You do the Treatment Again?(Week 16, 24, 32, 40 and 48)
- 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)
- Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment(Weeks 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?(Week 16, 24, 32, 40 and 48)
- Change in Wrinkle Assessment Scale (WAS) Score(Weeks 16, 24, 32, and 40)
- Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment(Weeks 16, 24, 32, 40, and 48.)
- FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire(Baseline and at weeks 24, 32, 40 and 48)
- Satisfaction With Treatment: Does the Treatment Make You Look Younger?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?(Week 16, 24, 32, 40 and 48)
- Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?(Week 16, 24, 32, 40 and 48)
Investigators
Study Sites (6)
Loading locations...
Similar Trials
Completed
Not Applicable
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek WrinklesCheek WrinklesNCT04124692Galderma R&D149
Completed
Not Applicable
Sculptra Chart ReviewNon-facial Skin Aesthetic ConditionsNCT05463978Galderma R&D498
Completed
Not Applicable
Sunstone IPL (Intense Pulsed Light) for Hair ReductionHair RemovalNCT03921814Philips Healthcare102
Completed
Not Applicable
Disrupt CAD IV With the Shockwave Coronary IVL SystemCoronary Artery DiseaseMyocardial InfarctionNCT04151628Shockwave Medical, Inc.72
Completed
Phase 3
Bioseal Dural Sealing Study BIOS-14-001Benign TumorsMalignant TumorsVascular MalformationNCT03110783Guangzhou Bioseal Biotechnology Co., Ltd.200