N/A
N=80
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
Nasolabial Folds
Bottom Line
View on ClinicalTrials.gov: NCT03780244 ↗Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Nov 2022
Primary outcome: Primary: Change in Wrinkle Assessment Scale (WAS) Score — -1.3; -1.3; -1.2; -1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sculptra Aesthetic 8ml (Device); Sculptra Aesthetic 5ml (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wrinkle Assessment Scale (WAS) Score |
-1.3; -1.5; -1.1; -1.5; -1.2; -1.4 | — |
| SECONDARY Change in Wrinkle Assessment Scale (WAS) Score |
-1.3; -1.5; -1.1; -1.5; -1.2; -1.4 | — |
| SECONDARY Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment |
54; 20; 53; 20; 52; 20 | — |
| SECONDARY Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment |
56; 21; 58; 21; 57; 21 | — |
| SECONDARY FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire |
37.8; 39.4; 75.3; 81.2; 72.4; 73.2 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look Younger? |
29; 11; 19; 10; 6; 0 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness? |
21; 8; 23; 12; 10; 1 | — |
| SECONDARY Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself? |
24; 11; 19; 10; 11; 0 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? |
21; 7; 19; 12; 15; 2 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? |
23; 8; 26; 12; 6; 1 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? |
16; 5; 23; 11; 15; 5 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? |
16; 5; 25; 13; 14; 3 | — |
| SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance? |
24; 9; 21; 10; 9; 2 | — |
| SECONDARY Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it? |
37; 17; 14; 4; 2; 0 | — |
| SECONDARY Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking? |
38; 17; 16; 4; 2; 0 | — |
| SECONDARY Subject Satisfaction With Treatment: Would You do the Treatment Again? |
53; 19; 4; 2; 54; 17 | — |
| SECONDARY Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend? |
52; 21; 5; 0; 53; 20 | — |
| SECONDARY Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting |
1.4; 2; 1.6; 1; 1.5; 1.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03780244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.