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NCT04595331 Clinical Trial

Open Label Extension for 43USSA1812

Wrinkle Clinical Trial

Official title:
Open Label Extension for 43USSA1812 (A Randomized, Evaluator-blinded, No-treatment Controlled, Multi-center Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04595331
Other study ID # 43USSA1812ext
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2020
Est. completion date July 20, 2022

Study information
Verified date August 2022
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date July 20, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: 1. Subject completed Month 12 of study 43USSA1812 2. Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent. Exclusion Criteria: 1. For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles

Locations
Country Name City State
United States Galderma Research Site Alpharetta Georgia
United States Galderma Research Site Coral Gables Florida
United States Galderma Research Site Dallas Texas
United States Galderma Research Site Encino California
United States Galderma Research Site New Orleans Louisiana
United States Galderma Research Site New York New York
United States Galderma Research Site New York New York
United States Galderma Research Site Redondo Beach California
United States Galderma Research Site Rockville Maryland
United States Galderma Research site San Diego California
United States Galderma Research Site Scottsdale Arizona
United States Galderma Research Site Spring Texas
United States Galderma Research Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently Month 19
Primary Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently Month 21
Primary Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently Month 24
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