Sculptra Chart Review

October 21, 2022 updated by: Galderma R&D

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Galderma Research Site
      • San Diego, California, United States, 92121
        • Galderma Research Site
      • Solana Beach, California, United States, 92075
        • Galderma Research Site
    • Florida
      • Coral Gables, Florida, United States, 33143
        • Galderma Research Site
      • Fort Lauderdale, Florida, United States, 33301
        • Galderma Research Site
    • New York
      • New York, New York, United States, 10021
        • Galderma Research Site
      • New York, New York, United States, 10012
        • Site Coordinator
      • New York, New York, United States, 10075
        • Galderma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Females/males treated with Sculptra Aesthetic in non-facial areas

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Females/Males treated with Sculptra Aesthetic in non-facial areas
Sculptra Aesthetic administration in non-facial areas
Device: Sculptra Aesthetic
Sculptra Aesthetic in non-facial areas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate safety of Sculptra Aesthetic when used in non-facial areas
Time Frame: January 2018 to 2022
AEs related to the product or injection procedure reported in the medical chart
January 2018 to 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Actual)

October 14, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

July 14, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 43USSA2110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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