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Sculptra Aesthetic Post-Approval Study

NCT ID: NCT02425943

Last Updated: 2023-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

867 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-21

Study Completion Date

2021-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasolabial Fold Contour Deficiencies Wrinkles

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sculptra Aesthetic

Group Type EXPERIMENTAL

injectable poly-L-lactic acid Sculptra Aesthetic

Intervention Type DEVICE

Interventions

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injectable poly-L-lactic acid Sculptra Aesthetic

Intervention Type DEVICE

Other Intervention Names

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Sculptra Aesthetic

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Operations

Role: STUDY_CHAIR

Galderma R&D

Locations

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Galderma Study Site

Birmingham, Alabama, United States

Site Status

Galderma Study Site

Encino, California, United States

Site Status

Galderma Study Site

Hermosa Beach, California, United States

Site Status

Galderma Study Site

San Diego, California, United States

Site Status

Galderma Study Site

Solana Beach, California, United States

Site Status

Galderma Study Site

Aventura, Florida, United States

Site Status

Galderma Study Site

Boca Raton, Florida, United States

Site Status

Galderma Study Site

Coral Gables, Florida, United States

Site Status

Galderma Study Site

Miami, Florida, United States

Site Status

Galderma Study Site

Buffalo Grove, Illinois, United States

Site Status

Galderma Study Site

Hackensack, New Jersey, United States

Site Status

Galderma Study Site

New York, New York, United States

Site Status

Galderma Study Site

White Plains, New York, United States

Site Status

Galderma Study Site

Nashville, Tennessee, United States

Site Status

Galderma Study Site

Austin, Texas, United States

Site Status

Galderma Study Site

Houston, Texas, United States

Site Status

Galderma Study Site

Plano, Texas, United States

Site Status

Galderma Study Site

Spokane, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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GLI.04.SPR.US10321

Identifier Type: -

Identifier Source: org_study_id

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