Phase 4 N=867 Treatment

Sculptra Aesthetic Post-Approval Study

Nasolabial Fold Contour Deficiencies · Wrinkles

Bottom Line

View on ClinicalTrials.gov: NCT02425943 ↗

Enrolled (actual)

867

Serious AEs

5.8%

Results posted

Jul 2023

Primary outcome: Primary: Percentage of Participants With Any Injection Site Nodule and/or Papule — 30.52; 24.84 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: injectable poly-L-lactic acid Sculptra Aesthetic (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: May 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Any Injection Site Nodule and/or Papule	30.52; 24.84	—
PRIMARY Percentage of Participants With Any Adverse Events of Interest (AEIs)	30.9; 25.8	—
SECONDARY Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	-1.73; -1.82; -1.74; -1.70; -1.60; -1.63	—
SECONDARY Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	-1.54; -1.88; -1.49; -1.96; -1.47; -1.89	—
SECONDARY Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	-1.72; -1.87; -1.65; -1.76; -1.52; -1.59	—
SECONDARY Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5	-1.54; -1.72; -1.46; -1.71; -1.37; -1.61	—
SECONDARY Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale	99.4; 99.6; 0.6; 0.4; 99.2; 99.6	—
SECONDARY Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale	97.2; 97.8; 2.8; 2.2; 97.4; 97.4	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects seeking correction of shallow to deep NLF contour deficiencies.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02425943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.