Clinical trial NCT04225273: Extension Study for 43USSA1705
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change From Baseline on Both Sides of the Face as Assessed by the Evaluator Using the WAS at Weeks 72 and 96
timeFrame: Baseline of study 43USSA1705 (NCT03780244), Weeks 72 and 96 (assessed in the current extension study)
Secondary outcomes:
measure: Number of Participants (Responders) Assessed Using the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Number of Participants (Responders) Assessed Using the GAIS Based on the Investigator Live Assessment
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: FACE-Q™ Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Would You do the Treatment Again?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Look Younger?
timeFrame: At Weeks 72 and 96 (assessed in the current extension study)
measure: Number of Participants With At Least One Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From Baseline of study 43USSA1705 (NCT03780244) up to Week 96 (assessed in the current extension study)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Galderma Study Site
state: Arizona
city: Bradenton
country: United States
facility: Galderma Study Site
state: Florida
city: Austin
country: United States
facility: Galderma Study Site
state: Texas
city: Spring
country: United States
facility: Galderma Study Site
state: Texas
Study officials:
References: