N/A
N=149
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Cheek Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT04124692 ↗Enrolled (actual)
149
Serious AEs
2.0%
Results posted
Nov 2023
Primary outcome: Primary: Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12 — 26.1; 71.6 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sculptra Aesthetic new dilution (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Aug 2021
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 at Month 12 |
26.1; 71.6 | <0.0001 sig |
| SECONDARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9 |
38.6; 66.2; 31.1; 70.6 | = 0.0043 sig |
| SECONDARY Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12 |
27.3; 67.5; 22.2; 64.7; 28.3; 70.5 | — |
| SECONDARY Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment |
29.5; 53.6; 34.1; 57.1 | — |
| SECONDARY Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment |
7.0; 93.5; 6.8; 89.4; 6.5; 92.0 | — |
| SECONDARY Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment |
6.8; 96.1; 4.4; 92.9; 4.3; 94.3 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look Younger? |
13; 24; 15; 19; 6; 19 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself? |
18; 20; 17; 18; 4; 18 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence? |
14; 24; 16; 18; 5; 18 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance? |
17; 23; 13; 19; 5; 19 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life? |
19; 19; 16; 18; 5; 17 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel? |
18; 19; 12; 18; 10; 21 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness? |
18; 24; 17; 13; 5; 25 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance? |
21; 19; 13; 19; 5; 23 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging? |
15; 23; 20; 7; 12; 23 | — |
| SECONDARY Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed? |
16; 23; 19; 12; 7; 23 | — |
| SECONDARY Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking? |
47; 25; 4; 1; 0; 48 | — |
| SECONDARY Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It? |
36; 27; 11; 2; 1; 41 | — |
| SECONDARY Subject Satisfaction: Would You Recommend the Treatment to a Friend? |
78; 10 | — |
| SECONDARY Subject Satisfaction: Would You do the Treatment Again? |
76; 12 | — |
| SECONDARY Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores |
21.3; 31.6; 38.6; -4.1; 38.6; -3.6 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
3; 43; 0; 3 | — |
Summary
The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.
Eligibility Criteria
Inclusion Criteria
- Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.
Exclusion Criteria
- Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
- Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:
- Collagen, Hyaluronic Acid - 12 months
- Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
Data sourced from ClinicalTrials.gov (NCT04124692). 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.