Non-facial Skin Aesthetic Conditions
Conditions
Brief summary
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
Interventions
DEVICESculptra Aesthetic
Sculptra Aesthetic in non-facial areas
Sponsors
Galderma R&D
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants who have been treated at the site with Sculptra Aesthetic in non-facial areas * Participants with available information about treatment dates and treatment procedures
Exclusion criteria
* Participant that have actively asked not to be involved in a study or registry * Other conditions that in the Investigator's opinion would exclude the participant from participation ; the condition should be recorded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart | Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days) | Related AE was defined as a reasonable possibility that Sculptra Aesthetic or the injection procedure might have caused the event. AEs related to Sculptra Aesthetic or the injection procedure in non-facial areas were identified by review of the medical charts of between January 2018 to December 2020 and reported in this outcome measure. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 9 investigational sites in the United States.
Pre-assignment details
A total of 498 participants were enrolled and observed retrospectively in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 11.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 155 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 250 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 289 Participants |
| Race (NIH/OMB) White | 166 Participants |
| Sex/Gender, Customized Sex/Gender Female | 480 Participants |
| Sex/Gender, Customized Sex/Gender Male | 17 Participants |
| Sex/Gender, Customized Sex/Gender Other | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 498 |
| other Total, other adverse events | 33 / 498 |
| serious Total, serious adverse events | 0 / 498 |
Outcome results
None listed