Extension Study for 43USSA1705

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-01-29

Brief Summary

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To evaluate the long-term 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sculptra Aesthetic

Participants who completed 48 weeks of Sculptra Aesthetic reconstituted with 8 milliliters (mL) of sterile water for injection (SWFI) in study 43USSA1705 (NCT03780244) were followed into this long-term extension study at Week 72 and Week 96 after baseline (i.e., Day 1/first treatment session with Sculptra Aesthetic in Study 43USSA1705 \[NCT03780244\]). No investigational product was provided during this extension study.

Group Type EXPERIMENTAL

Sculptra Aesthetic, Lidocaine HCL

Intervention Type DEVICE

No intervention was administered during this extension study.

Interventions

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Sculptra Aesthetic, Lidocaine HCL

No intervention was administered during this extension study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705

Exclusion Criteria

* Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion
* Other condition preventing the subject from entering the study in the Investigator's opinion
* Participation in any interventional clinical study throughout the duration of the study

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No