Status:
COMPLETED
Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.
Lead Sponsor:
Galderma R&D
Conditions:
Nasolabial Folds
Eligibility:
All Genders
22+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
- Collagen, Hyaluronic Acid- 12 months
- 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.
Key Trial Info
Start Date :
December 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03780244
Start Date
December 18 2018
End Date
February 28 2020
Last Update
November 14 2022
Active Locations (5)
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1
Galderma Study Site
Scottsdale, Arizona, United States, 85255
2
Galderma Study Site
Solana Beach, California, United States, 92075
3
Galderma Study Site
Bradenton, Florida, United States, 34209
4
Galderma Study Site
Austin, Texas, United States, 78746