Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2020-02-28

Brief Summary

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This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

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Detailed Description

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Conditions

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Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Investigational Study Product

Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection (SWFI)

Group Type EXPERIMENTAL

Sculptra Aesthetic 8ml

Intervention Type DEVICE

Treatment of nasolabial folds

Reference Product

Injection with Sculptra Aesthetic reconstituted with 5ml SWFI

Group Type ACTIVE_COMPARATOR

Sculptra Aesthetic 5ml

Intervention Type DEVICE

Treatment of nasolabial folds

Interventions

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Sculptra Aesthetic 8ml

Treatment of nasolabial folds

Intervention Type DEVICE

Sculptra Aesthetic 5ml

Treatment of nasolabial folds

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.

Exclusion Criteria

* Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.

1. Collagen, Hyaluronic Acid- 12 months
2. Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes