Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-20
Brief Title:
Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies
Sponsor:
Galderma RD
Organization:
Galderma RD
Study Overview
Official Title:
A Multi-center Open-label Study to Evaluate the Synergistic Effects of Biostimulator and Dermal Fillers for Cheek Augmentation and Correction of Contour Deficiencies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adult subjects with a history of or currently taking glucagon-like peptide-1 GLP-1 receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies
Detailed Description:
This is a multi-center open-label study Subjects will be screened on the basis of the selection criteria for study qualification Eligible subjects will have initial treatment of Sculptra and Restylane Lyft or Restylane Contour on both cheeks at the Baseline visit
At Week 4 subjects will receive a second Sculptra treatment on both cheeks for optimal correction and an optional touch-up of Restylane Lyft or Restylane Contour for optimal correction defined as at least a 1-grade improvement on the GCWS and MMVS
At Week 8 subjects will receive an optional Sculptra treatment on both cheeks for optimal correction
Subjects will have follow-up visits at Week 16 Week 28 and Week 40 if the last Sculptra treatment is at Week 4 or at Week 20 Week 32 and Week 44 if the last Sculptra treatment is at Week 8
At Week 4 subjects will receive a second Sculptra treatment on both cheeks for optimal correction and an optional touch-up of Restylane Lyft or Restylane Contour for optimal correction defined as at least a 1-grade improvement on the GCWS and MMVS
At Week 8 subjects will receive an optional Sculptra treatment on both cheeks for optimal correction
Subjects will have follow-up visits at Week 16 Week 28 and Week 40 if the last Sculptra treatment is at Week 4 or at Week 20 Week 32 and Week 44 if the last Sculptra treatment is at Week 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None