CompletedPhase 4

Sculptra Aesthetic Post-Approval Study

United States867 participantsStarted 2015-05-21

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕. 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.
✕. Subjects that are less than 18 or greater than 75 years of age.

What they're measuring

Percentage of Participants With Any Injection Site Nodule and/or Papule

Timeframe: Up to 5 years

Percentage of Participants With Any Adverse Events of Interest (AEIs)

Timeframe: Up to 5 years

Trial details

NCT IDNCT02425943

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-28

Results submitted2023-04-14

View on ClinicalTrials.gov More Nasolabial Fold Contour Deficiencies trials