Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sculptra Aesthetic | Device | Sculptra Aesthetic in non-facial areas |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart | 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. | Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Females/males treated with Sculptra Aesthetic in non-facial areas
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Pasadena | California | 91105 | United States | ||
| Galderma Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 498 participants were enrolled and observed retrospectively in this study.
The study was conducted at 9 investigational sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full analysis set (FAS) included participants fulfilling all inclusion criteria and none of the exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart | 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. | Analysis was performed on the FAS. FAS included participants fulfilling all inclusion criteria and none of the exclusion criteria. | Posted | Count of Participants | Participants | Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days) |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma | 817-961-5000 | aestheticlinicaltrials@galderma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 3, 2022 | May 18, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2022 | May 18, 2026 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
| San Diego |
| California |
| 92121 |
| United States |
| Galderma Research Site | Solana Beach | California | 92075 | United States |
| Galderma Research Site | Coral Gables | Florida | 33143 | United States |
| Galderma Research Site | Fort Lauderdale | Florida | 33301 | United States |
| Site Coordinator | New York | New York | 10012 | United States |
| Galderma Research Site | New York | New York | 10021 | United States |
| Galderma Research Site | New York | New York | 10075 | United States |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 498 |
| 0 |
| 498 |
| 33 |
| 498 |
| Injection site oedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Injection site haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Injection site discomfort | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Injection site erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Tenderness | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Injection site haematoma | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Injection site nodule | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Pain | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
Not provided