Sculptra Aesthetic Post-Approval Study

Galderma

Status and phase: Completed; Phase 4

Conditions: Wrinkles; Nasolabial Fold Contour Deficiencies

Treatments: Device: injectable poly-L-lactic acid Sculptra Aesthetic

Study type: Interventional

Funder types: Industry

Identifiers

NCT02425943

GLI.04.SPR.US10321

Details and patient eligibility

About

Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and other facial wrinkles.

Enrollment: 867 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

Exclusion criteria

1. Subjects seeking, at entry into the study, correction of other facial wrinkles with Sculptra Aesthetic in the following anatomical sites/lines: horizontal forehead lines, glabellar frown lines, periorbital lines, periauricular lines, upper lip lines, lower lip lines, corner of the mouth lines and/or horizontal neck folds.
2. Subjects that are less than 18 or greater than 75 years of age.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

867 participants in 1 patient group

Sculptra Aesthetic

Experimental group

Treatment:

Device: injectable poly-L-lactic acid Sculptra Aesthetic