Extension Study for 43USSA1705

Nasolabial Folds Clinical Trial

Official title:

Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225273
• Other study ID #: 43USSA1705ext
• Status: Completed
• Phase: N/A
• Start date: December 3, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: September 2021
• Source: Q-Med AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 29, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• Sculptra Aesthetic 8 ml and Lidocaine
Treatment of nasolabial folds

Locations

Country	Name	City	State
United States	Galderma Study Site	Austin	Texas
United States	Galderma Study Site	Bradenton	Florida
United States	Galderma Study Site	Scottsdale	Arizona
United States	Galderma Study Site	Spring	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Q-Med AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events collected throughout the study period		Baseline (initial treatment in pivotal study 43USSA1705) to Week 96
Primary	Intensity of adverse events collected throughout the study period		Baseline (initial treatment in pivotal study 43USSA1705) to Week 96
Primary	Time to onset of adverse events collected throughout the study period		Baseline (initial treatment in pivotal study 43USSA1705) to Week 96
Primary	Duration of adverse events collected throughout the study period		Baseline (initial treatment in pivotal study 43USSA1705) to Week 96
Primary	Change from baseline on both sides of the face as assessed by the Evaluator using the Wrinkle Assessment Scale (WAS)		Weeks 72 and 96 after Baseline
Primary	Responder rate using the Global Aesthetic Improvement Scale (GAIS)		Weeks 72 and 96 after Baseline
Primary	FACE-Q Appraisal of Lines: Nasolabial Folds Questionnaire		Weeks 72 and 96 after Baseline
Primary	Subject satisfaction score using a 5-point subject satisfaction questionnaire		Weeks 72 and 96 after Baseline