Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2026-01-04 @ 8:37 AM
Study NCT ID:
NCT06351358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies
Sponsor:
Galderma R&D
Organization:
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:
2024-12
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:
False
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?:
False
Is an FDA AA801 Violation?: