Clinical trial NCT04124692: Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Official title: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek Wrinkles
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 149
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study has been designed to evaluate the safety and effectiveness of Sculptra Aesthetic as a single regimen for correction of cheek wrinkles after changes in reconstitution and injection procedures compared to the approved label.


Eligibility criteria: Inclusion Criteria:

* Intent to undergo correction of cheek wrinkles on both sides of the face and a Galderma Cheek Wrinkles Scale (GCWS) At Rest score of Moderate or Severe on EACH side of the face.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.
* Previous tissue augmenting therapy, contouring or revitalization treatment in the face, except the lips, with any of the following fillers prior to Baseline visit:

  1. Collagen, Hyaluronic Acid - 12 months
  2. Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited

Primary outcomes:
measure: Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12
timeFrame: At Month 12
Secondary outcomes:
measure: Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9
timeFrame: At Months 7 and 9
measure: Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
timeFrame: At Months 7, 9, and 12
measure: Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment
timeFrame: At Month 12
measure: Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
timeFrame: At Months 7, 9, and 12
measure: Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Make You Look Younger?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Make You Feel Better About Yourself?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Improve Your Skin Firmness?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Improve Your Skin Radiance?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Improve Your Skin Sagging?
timeFrame: At Months 7, 9, and 12
measure: Satisfaction With Treatment: Does the Treatment Make Your Skin Look More Refreshed?
timeFrame: At Months 7, 9, and 12
measure: Subject Satisfaction: Would You Say That the Treatment Results Are Natural Looking?
timeFrame: At Months 7, 9, and 12
measure: Subject Satisfaction: Would You Say the Subtle Changes Over Time Was Worth It?
timeFrame: At Months 7, 9, and 12
measure: Subject Satisfaction: Would You Recommend the Treatment to a Friend?
timeFrame: At Month 12
measure: Subject Satisfaction: Would You do the Treatment Again?
timeFrame: At Month 12
measure: Change From Baseline in Satisfaction With Cheeks FACE-Q™ Questionnaire Rasch-transformed Total Scores
timeFrame: Treatment group: Baseline, Months 1, 2, 3, 7, 9 and 12; Control group: Baseline, Months 7, 9 and 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From start of study drug administration up to end of the study (up to Month 12)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Galderma Research Site
state: Arizona
city: Encino
country: United States
facility: Galderma Research Site
state: California
city: Redondo Beach
country: United States
facility: Galderma Research Site
state: California
city: San Diego
country: United States
facility: Galderma Research Site
state: California
city: Washington
country: United States
facility: Galderma Research Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: Alpharetta
country: United States
facility: Galderma Research Site
state: Georgia
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: Rockville
country: United States
facility: Galderma Research Site
state: Maryland
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Dallas
country: United States
facility: Galderma Research Site
state: Texas
city: Spring
country: United States
facility: Galderma Research Site
state: Texas
Study officials:
References: