Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT06351358
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.
Study:
NCT06351358
Study Brief:
Protocol Section:
NCT06351358