deltatrials
Completed INTERVENTIONAL NCT06351358

Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies

A Multi-center, Open-label Study to Evaluate the Synergistic Effects of Biostimulator and Dermal Fillers for Cheek Augmentation and Correction of Contour Deficiencies

Sponsor: Galderma R&D

Updated 7 times since 2024 Last updated: Apr 13, 2026 Started: Feb 19, 2024 Primary completion: May 31, 2025 Completion: May 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Photoaging and Photodamaged Skin, this trial is completed. The trial is conducted by Galderma R&D and has accumulated 7 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Sep 2025 · 8 months · monthly snapshotActive Not Recruiting~Sep 2025 – ~Apr 2026 · 7 months · monthly snapshotActive Not RecruitingApr 16, 2026 – present · 5 months · daily APICompleted

Change History

7 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Completed

    Status: Active Not RecruitingCompleted · Phase: NANone

  2. Sep 2025 — Apr 2026 [monthly]

    Active Not Recruiting NA

  3. Jan 2025 — Sep 2025 [monthly]

    Active Not Recruiting NA

  4. Nov 2024 — Jan 2025 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  5. Sep 2024 — Nov 2024 [monthly]

    Recruiting NA

Show 2 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  2. May 2024 — Jul 2024 [monthly]

    Recruiting NA

    First recorded

Feb 2024

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Galderma R&D
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .