Status:
COMPLETED
Safety and Effectiveness of Sculptra Aesthetic for Correction of Cheek Wrinkles
Lead Sponsor:
Galderma R&D
Conditions:
Cheek Wrinkles
Eligibility:
All Genders
21+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT04124692
Start Date
November 12 2019
End Date
August 12 2021
Last Update
November 18 2023
Active Locations (13)
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1
Galderma Research Site
Scottsdale, Arizona, United States, 85255
2
Galderma Research Site
Encino, California, United States, 91436
3
Galderma Research Site
Redondo Beach, California, United States, 90277
4
Galderma Research Site
San Diego, California, United States, 92121