Trial Outcomes & Findings for Sculptra Chart Review (NCT NCT05463978)
NCT ID: NCT05463978
Last Updated: 2026-06-12
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
498 participants
Primary outcome timeframe
Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Results posted on
2026-06-12
Participant Flow
The study was conducted at 9 investigational sites in the United States.
A total of 498 participants were enrolled and observed retrospectively in this study.
Participant milestones
| Measure |
Sculptra Aesthetic
Participants who had been treated with at least 2 vials in each of at least 2 different treatment sessions of Sculptra Aesthetic injections in non-facial areas during the period January 2018 to December 2020 and had searchable charts with treatments documented were observed retrospectively in this study.
|
|---|---|
|
Overall Study
STARTED
|
498
|
|
Overall Study
COMPLETED
|
498
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sculptra Chart Review
Baseline characteristics by cohort
| Measure |
Sculptra Aesthetic
n=498 Participants
Participants who had been treated with at least 2 vials in each of at least 2 different treatment sessions of Sculptra Aesthetic injections in non-facial areas during the period January 2018 to December 2020 and had searchable charts with treatments documented were observed retrospectively in this study.
|
|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 11.83 • n=9 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Female
|
480 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Male
|
17 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Sex/Gender · Other
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
250 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
289 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)Population: Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
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.
Outcome measures
| Measure |
Sculptra Aesthetic
n=498 Participants
Participants who had been treated with at least 2 vials in each of at least 2 different treatment sessions of Sculptra Aesthetic injections in non-facial areas during the period January 2018 to December 2020 and had searchable charts with treatments documented were observed retrospectively in this study.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart
|
33 Participants
|
Adverse Events
Sculptra Aesthetic
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sculptra Aesthetic
n=498 participants at risk
Participants who had been treated with at least 2 vials in each of at least 2 different treatment sessions of Sculptra Aesthetic injections in non-facial areas during the period January 2018 to December 2020 and had searchable charts with treatments documented were observed retrospectively in this study.
|
|---|---|
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Skin and subcutaneous tissue disorders
Injection site bruising
|
5.0%
25/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site oedema
|
0.80%
4/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site haemorrhage
|
0.60%
3/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site discomfort
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site erythema
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site haematoma
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Injection site nodule
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Nervous system disorders
Pain
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.20%
1/498 • Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place