Sculptra Chart Review
A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas
1 other identifier
observational
498
1 country
8
Brief Summary
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2022
CompletedStudy Start
First participant enrolled
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2022
CompletedResults Posted
Study results publicly available
June 12, 2026
CompletedJune 12, 2026
May 1, 2026
3 months
July 14, 2022
May 18, 2026
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
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.
Interventions
Eligibility Criteria
Females/males treated with Sculptra Aesthetic in non-facial areas
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (8)
Galderma Research Site
Pasadena, California, 91105, United States
Galderma Research Site
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
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Galderma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 19, 2022
Study Start
July 14, 2022
Primary Completion
October 14, 2022
Study Completion
October 14, 2022
Last Updated
June 12, 2026
Results First Posted
June 12, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share