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
500
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
Click on a node to explore related trials.
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
CompletedOctober 24, 2022
September 1, 2022
3 months
July 14, 2022
October 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate safety of Sculptra Aesthetic when used in non-facial areas
AEs related to the product or injection procedure reported in the medical chart
January 2018 to 2022
Study Arms (1)
Females/Males treated with Sculptra Aesthetic in non-facial areas
Sculptra Aesthetic administration in non-facial areas
Interventions
Sculptra Aesthetic in non-facial areas
Eligibility Criteria
Females/males treated with Sculptra Aesthetic in non-facial areas
You may qualify if:
- Subjects who have been treated at the site with Sculptra Aesthetic in non-facial areas
- Subjects with available information about treatment dates and treatment procedures
You may not qualify if:
- Subject that have actively asked not to be involved in a study or registry
- Other conditions that in the Investigator's opinion would exclude the subject 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
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
October 24, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share