N/A N=38 Treatment

Extension Study for 43USSA1705

Nasolabial Folds

Bottom Line

View on ClinicalTrials.gov: NCT04225273 ↗

Enrolled (actual)

Serious AEs

2.6%

Results posted

Mar 2025

Primary outcome: Primary: Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96 — -1.3; -1.2; -1.2; -1.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sculptra Aesthetic, Lidocaine HCL (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96	-1.3; -1.2; -1.2; -1.1	—
SECONDARY Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	30; 30	—
SECONDARY Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment	35; 35	—
SECONDARY FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire	69.8; 70.2	—
SECONDARY Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?	33; 2; 31; 4	—
SECONDARY Subject Satisfaction With Treatment: Would You do the Treatment Again?	32; 3; 32; 3	—
SECONDARY Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?	18; 14; 2; 1; 0; 20	—
SECONDARY Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?	26; 7; 1; 0; 1; 20	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?	14; 14; 4; 2; 1; 13	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?	11; 16; 5; 3; 0; 10	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?	12; 16; 4; 3; 0; 11	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?	14; 13; 5; 3; 0; 12	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?	12; 17; 3; 3; 0; 12	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?	17; 13; 2; 3; 0; 13	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?	11; 18; 3; 3; 0; 12	—
SECONDARY Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?	13; 18; 1; 3; 0; 13	—
SECONDARY Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	24; 1	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04225273). 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.