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.

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

Nasolabial Folds

Sculptra Aesthetic 8ml

Sculptra Aesthetic 5ml

A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

The WAS is a validated photograph-based outcome instrument that is designed specifically
for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0
representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based
on visual live assessment by the Blinded Evaluator at defined timepoints and not on a
comparison to the baseline appearance.

Effectiveness is defined as change from baseline on both sides of the face using WAS at
48 Weeks after the first treatment session.

The WAS is a validated photograph-based outcome instrument that is designed specifically
for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0
representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based
on visual live assessment by the Blinded Evaluator at defined timepoints and not on a
comparison to the baseline appearance.

Effectiveness is defined as change from baseline on both sides of the face as assessed by
the Blinded Evaluator using WAS at X weeks

Responders defined as at least "improved" (improved, much improved, very much improved)
as assessed by the subject

Responders defined as at least "improved" (improved, much improved, very much improved)
as assessed by the Treating Investigator

Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score
(0-100) according to the FACE-Q manual; the higher total score indicated greater subject
satisfaction

A 5-point subject satisfaction questionnaire with the following responses: Very
Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

A 5-point subject satisfaction questionnaire with the following responses: Strongly
Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.

A subject satisfaction question with responses Yes or No.

Subjects were asked to complete the following questions in the subject diary:

  -  Did you feel comfortable to return to social engagement today? (Yes or No)

  -  If yes, what was the earliest time you felt comfortable to return to social
     engagement? (Record date and time [using 24-hour clock])

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

Injection with Sculptra Aesthetic reconstituted with 5ml SWFI

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status