Non-facial Skin Aesthetic ConditionsNCT05463978
Sculptra Chart Review
An observational study of Non-facial Skin Aesthetic Conditions, run by Galderma R&D at 8 sites in United States.
Trial summary
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-facial Skin Aesthetic Conditions
- What is being tested?
- Sculptra Aesthetic
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 498 participants
- Where
- 8 sitesUnited States
- Study dates
- 14 Jul 2022to 14 Oct 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Females/males treated with Sculptra Aesthetic in non-facial areas
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Galderma Research Site
Coral Gables, Florida, 33143
Galderma Research Site
Fort Lauderdale, Florida, 33301
Site Coordinator
New York, New York, 10012
Galderma Research Site
New York, New York, 10021
Galderma Research Site
New York, New York, 10075
Galderma Research Site
Pasadena, California, 91105
Galderma Research Site
San Diego, California, 92121
Galderma Research Site
Solana Beach, California, 92075
About this study
Official title: A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
- Conditions
- Non-facial Skin Aesthetic Conditions
- Being tested
- Sculptra Aesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra AestheticDevice
Sculptra Aesthetic in non-facial areas
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sculptra Aesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start14 Jul 2022
- Primary completion14 Oct 2022
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-facial Skin Aesthetic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463978
- Sponsor's protocol ID
- 43USSA2110
- Status last verified
- May 2026
- First submitted
- 14 Jul 2022
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas
- ClinicalTrials.gov ID
- NCT05463978
- Acronym / sponsor ID
- 43USSA2110
- Conditions
- Non-facial Skin Aesthetic Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sculptra Aesthetic | – | Device: Sculptra AestheticParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females/males treated with Sculptra Aesthetic in non-facial areas
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sculptra AestheticSculptra Aesthetic in non-facial areas | Device | Sculptra Aesthetic |
Primary outcome
Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-facial Skin Aesthetic Conditions, run by Galderma R&D at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) Related to the Sculptra Aesthetic Reported in the Medical Chart (time frame: Retrospective data was retrieved and observed during the period from January 2018 to 24 September 2022 (up to 1728 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.