Clinical trial NCT03780244: Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
Official title: 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: 2018-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has been designed to evaluate the 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:

* Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.

Exclusion Criteria:

* Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.

  1. Collagen, Hyaluronic Acid- 12 months
  2. Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

Primary outcomes:
measure: Change in Wrinkle Assessment Scale (WAS) Score
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in Wrinkle Assessment Scale (WAS) Score
timeFrame: Weeks 16, 24, 32, and 40
measure: Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment
timeFrame: Weeks 16, 24, 32, 40, and 48.
measure: Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment
timeFrame: Weeks 16, 24, 32, 40 and 48
measure: FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire
timeFrame: Baseline and at weeks 24, 32, 40 and 48
measure: Satisfaction With Treatment: Does the Treatment Make You Look Younger?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Would You do the Treatment Again?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?
timeFrame: Week 16, 24, 32, 40 and 48
measure: Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting
timeFrame: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Galderma Study Site
state: Arizona
city: Solana Beach
country: United States
facility: Galderma Study Site
state: California
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: