Clinical trial NCT02425943: Sculptra Aesthetic Post-Approval Study
Official title: A Prospective, Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Sculptra®Aesthetic in Immuno-Competent Subjects Stratified by Fitzpatrick Skin Type I-VI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Fold Contour Deficiencies
Wrinkles
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 867
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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:

1. Subjects seeking correction of shallow to deep NLF contour deficiencies.

Exclusion Criteria:

1. 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.
2. Subjects that are less than 18 or greater than 75 years of age.

Primary outcomes:
measure: Percentage of Participants With Any Injection Site Nodule and/or Papule
timeFrame: Up to 5 years
measure: Percentage of Participants With Any Adverse Events of Interest (AEIs)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Change From Baseline in Nasolabial Folds (NLF) Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
timeFrame: Baseline, Months 6,13 and Years 2,3 4,5
measure: Change From Baseline in Cheek Folds Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
timeFrame: Baseline, Months 6,13 and Years 2,3 4,5
measure: Change From Baseline in Marionette Lines Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
timeFrame: Baseline, Months 6,13 and Years 2,3 4,5
measure: Change From Baseline in Chin Crease Wrinkle Assessment Score (WAS) at Months 6, 13, and Years 2, 3, 4, and 5
timeFrame: Baseline, Months 6,13 and Years 2,3 4,5
measure: Percentage of Participants Improved Versus Not Improved on Investigator Assessment of Facial Appearance Using Global Assessment Scale
timeFrame: At 6,13 months, 2, 3, 4 and 5 years
measure: Percentage of Participants Improved Versus Not Improved on Participant Assessment of Facial Appearance Using Global Assessment Scale
timeFrame: At 6,13 months, 2, 3, 4 and 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Study Site
state: Alabama
city: Encino
country: United States
facility: Galderma Study Site
state: California
city: Hermosa Beach
country: United States
facility: Galderma Study Site
state: California
city: San Diego
country: United States
facility: Galderma Study Site
state: California
city: Solana Beach
country: United States
facility: Galderma Study Site
state: California
city: Aventura
country: United States
facility: Galderma Study Site
state: Florida
city: Boca Raton
country: United States
facility: Galderma Study Site
state: Florida
city: Coral Gables
country: United States
facility: Galderma Study Site
state: Florida
city: Miami
country: United States
facility: Galderma Study Site
state: Florida
city: Buffalo Grove
country: United States
facility: Galderma Study Site
state: Illinois
city: Hackensack
country: United States
facility: Galderma Study Site
state: New Jersey
city: New York
country: United States
facility: Galderma Study Site
state: New York
city: White Plains
country: United States
facility: Galderma Study Site
state: New York
city: Nashville
country: United States
facility: Galderma Study Site
state: Tennessee
city: Austin
country: United States
facility: Galderma Study Site
state: Texas
city: Houston
country: United States
facility: Galderma Study Site
state: Texas
city: Plano
country: United States
facility: Galderma Study Site
state: Texas
city: Spokane
country: United States
facility: Galderma Study Site
state: Washington
Study officials:
affiliation: Galderma R&D
name: Clinical Operations
role: STUDY_CHAIR
References: