Clinical trial NCT04595331: Open Label Extension for 43USSA1812
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek
Wrinkle
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Subjects originally randomized to Control Group at baseline in the pivotal 43USSA1812 study will be offered treatment with Sculptra Aesthetic in the extension study. Subjects originally randomized to Treatment Group at baseline in the pivotal 43USSA1812 study will be continued to be followed up during the extension study without further treatment.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles
timeFrame: Month 19
measure: Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles
timeFrame: Month 21
measure: Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles
timeFrame: Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Galderma Research Site
state: Arizona
city: Encino
country: United States
facility: Galderma Research Site
state: California
city: Redondo Beach
country: United States
facility: Galderma Research Site
state: California
city: San Diego
country: United States
facility: Galderma Research site
state: California
city: Washington
country: United States
facility: Galderma Research Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Alpharetta
country: United States
facility: Galderma Research Site
state: Georgia
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: Rockville
country: United States
facility: Galderma Research Site
state: Maryland
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Dallas
country: United States
facility: Galderma Research Site
state: Texas
city: Spring
country: United States
facility: Galderma Research Site
state: Texas
Study officials:
References: