N/A
Completed N=111
Open Label Extension for 43USSA1812
Cheek · Wrinkle
Source: ClinicalTrials.gov NCT04595331 ↗
Enrolled (actual)
111
Serious AEs
0.9%
Results posted
Jun 2025
Primary outcomePrimary: Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest — 33.3; 84.8; 36.8; 76.9 Percentage of participants
Summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest |
33.3; 84.8; 36.8; 76.9; 42.1; 76.9 | — |
| SECONDARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic |
41.7; 77.3; 44.7; 75.4; 50; 73.8 | — |
| SECONDARY Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment |
97.2; 97.0; 97.4; 96.9; 92.3; 93.8 | — |
| SECONDARY Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment |
97.2; 97.0; 97.4; 96.9; 92.3; 93.8 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look Younger? |
8; 14; 8; 14; 10; 21 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? |
7; 14; 9; 18; 11; 19 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? |
5; 14; 10; 17; 12; 17 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? |
4; 16; 14; 14; 9; 20 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? |
3; 15; 12; 14; 12; 19 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? |
6; 13; 11; 14; 11; 18 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? |
9; 14; 12; 20; 7; 17 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? |
7; 14; 9; 18; 11; 19 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? |
7; 14; 8; 13; 13; 17 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? |
8; 18; 10; 14; 10; 13 | — |
| SECONDARY Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? |
22; 37; 10; 20; 4; 10 | — |
| SECONDARY Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? |
17; 30; 13; 21; 6; 11 | — |
| SECONDARY Subject Satisfaction: Would You Recommend the Treatment to a Friend? |
34; 56; 2; 11; 35; 58 | — |
| SECONDARY Subject Satisfaction: Would You do the Treatment Again? |
31; 55; 5; 12; 32; 58 | — |
| SECONDARY Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores |
42.9; 34.9; 44; 38.7; 45.3; 36.8 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
17; 15; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject completed Month 12 of study 43USSA1812
- Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
Exclusion Criteria
- For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
Data sourced from ClinicalTrials.gov (NCT04595331). 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. Informational only — not medical advice.