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NCT06351358 · ClinicalTrials.gov registry record · NA
Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies
A NA study of Weight Loss and Photoaging, sponsored by Galderma R&D.
- Active
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT06351358: Active NA study of Weight Loss and Photoaging, sponsored by Galderma R&D.
NCT06351358 is a NA study of Weight Loss and Photoaging that is active but no longer recruiting, run by Galderma R&D. The registered enrollment target is 40 participants, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06351358, a NA study of Weight Loss and Photoaging, is active but no longer recruiting, sponsored by Galderma R&D.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water).The locations of measurement will be at (1) the zygoma area in the Restylane-treated region using a ruler starting from the corner of the eye and (2) 2-3 cm laterally from the end of the earlobe in the Sculptra-injected region using a ruler starting from the end of the earlobe to the corner of the mouth
Conditions Studied
Interventions
- DEVICE Sculptra treatment
- DEVICE Restylane Treatment
Study Locations (2)
District of Columbia
- Somenek + Pittman MD: Advanced Plastic Surgery - Washington D.C.
New York
- Lorenc Aesthetic Plastic Surgery Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2025-05-31 |
| Phase | NA |
What the registry record for NCT06351358 still lists
NCT06351358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Weight Loss appearing as the primary indexed condition, and to 2 interventions - of which Sculptra treatment is the first listed.
NCT06351358 reports a single indexed study location in District of Columbia, New York.
Frequently Asked Questions
What is clinical trial NCT06351358 about?
NCT06351358 is a clinical study titled "Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies". 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 Restylan...
What is the current status of trial NCT06351358?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-02-19. Estimated completion is 2025-05-31.
What conditions does trial NCT06351358 study?
This clinical trial studies the following conditions: Weight Loss, Photoaging, Skin Laxity, Photodamaged Skin, Volume Deficiency of the Midface.
What interventions are being tested in trial NCT06351358?
The interventions under investigation include: Sculptra treatment (DEVICE), Restylane Treatment (DEVICE).
Who is sponsoring clinical trial NCT06351358?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351358 being conducted?
This trial has 2 study locations across District of Columbia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06351358's enrollment target sits among peer trials
40 87th of 116 higher than 26 of 116 other Weight Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Weight Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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