Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra Aesthetic for Correction of Cheek Wrinkles.
1 other identifier
interventional
149
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2021
CompletedResults Posted
Study results publicly available
November 18, 2023
CompletedNovember 18, 2023
November 1, 2023
1.8 years
October 10, 2019
October 12, 2023
November 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Cheek Wrinkles Scale (GCWS) at Rest at Month 12
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline on the GCWS, on both sides of the face, concurrently. GCWS is a validated 5-point scale used to assess the severity of cheek wrinkles: 0 (none \[no lines or wrinkles\]), 1 (mild \[only few superficial lines\]), 2 (moderate \[many superficial lines or a few shallow wrinkles\]), 3 (severe \[many shallow wrinkles or a few moderate depth wrinkles\]) and 4 (very severe \[many moderate wrinkles or at least one depth wrinkle with or without redundant folds\]). Higher score means more severe (worse) wrinkles. The participant was to have a relaxed face during the assessment.
At Month 12
Secondary Outcomes (21)
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS at Rest at Months 7 and 9
At Months 7 and 9
Responder Rate Based on the Blinded Evaluator's Live Assessment of the GCWS Dynamic at Months 7, 9 and 12
At Months 7, 9, and 12
Percentage of Participants With Improvement Rate Based on the Independent Photographic Reviewer's Assessment
At Month 12
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
At Months 7, 9, and 12
Percentage of Participants With At Least "Improved" on the GAIS Based on the Investigator Live Assessment
At Months 7, 9, and 12
- +16 more secondary outcomes
Study Arms (2)
Control Group: No-treatment
NO INTERVENTIONParticipants will receive no treatment during the study.
Treatment Group: Sculptra Aesthetic
EXPERIMENTALParticipants will be injected with Sculptra Aesthetic by Treating Investigator at Day 1 until optimal correction achieved (up to 4 total treatment sessions)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- Collagen, Hyaluronic Acid - 12 months
- Calcium Hydroxyapatite (CaHa), Poly L- Lactic Acid (PLLA) or permanent (nonbiodegradable)- Prohibited
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (13)
Galderma Research Site
Scottsdale, Arizona, 85255, United States
Galderma Research Site
Encino, California, 91436, United States
Galderma Research Site
Redondo Beach, California, 90277, United States
Galderma Research Site
San Diego, California, 92121, United States
Galderma Research Site
Washington D.C., District of Columbia, 20037, United States
Galderma Research Site
Coral Gables, Florida, 33143, United States
Galderma Research Site
Alpharetta, Georgia, 30022, United States
Galderma Research Site
New Orleans, Louisiana, 70115, United States
Galderma Research Site
Rockville, Maryland, 20852, United States
Galderma Research Site
New York, New York, 10021, United States
Galderma Research Site
New York, New York, 10028, United States
Galderma Research Site
Dallas, Texas, 75254, United States
Galderma Research Site
Spring, Texas, 77388, United States
Related Publications (1)
Fabi SG, Le JHTD, Prygova I, Brasater D. Midface Projection Using Biostimulatory Poly- l -Lactic Acid Injectable Implant: A Subgroup Analysis of the Cheek Wrinkle Trial. Dermatol Surg. 2024 Dec 1;50(12):1137-1142. doi: 10.1097/DSS.0000000000004434. Epub 2024 Oct 17.
PMID: 39453400DERIVED
Results Point of Contact
- Title
- Head of Development
- Organization
- Q-Med AB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 11, 2019
Study Start
November 12, 2019
Primary Completion
August 12, 2021
Study Completion
August 12, 2021
Last Updated
November 18, 2023
Results First Posted
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share