Open Label Extension for 43USSA1812

Galderma

Status: Completed

Conditions: Cheek; Wrinkle

Treatments: Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04595331

43USSA1812ext

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

Group A: Sculptra Aesthetic

Experimental group

Description:

Subjects in this group will be treated with Sculptra aesthetic. Subjects will be followed for up to 12 months for safety and effectiveness data collection

Treatment:

Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection

Group B: No Treatment

Experimental group

Description:

Subjects in this group will be followed for up to 12 months with no additional treatment for long-term safety and effectiveness data collection.

Treatment:

Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection