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NCT07419854 · ClinicalTrials.gov registry record · Phase 4
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
A Phase 4 study of Volume Loss (Soft Tissue Ptosis or Atrophy ), sponsored by Kalpna Kay Durairaj, MD, FACS.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT07419854: Recruiting Phase 4 study of Volume Loss (Soft Tissue Ptosis or Atrophy ), sponsored by Kalpna Kay Durairaj, MD, FACS.
NCT07419854 is a Phase 4 study of Volume Loss (Soft Tissue Ptosis or Atrophy ) that is actively recruiting participants, run by Kalpna Kay Durairaj, MD, FACS. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07419854, a Phase 4 study of Volume Loss (Soft Tissue Ptosis or Atrophy ), is actively recruiting participants, sponsored by Kalpna Kay Durairaj, MD, FACS.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate the potential of Calcium Hydroxylapatite (CaHA) to restore facial volume and improve skin quality in patients with GLP-1 receptor agonist-associated facial volume loss. Participants will: * Schedule first dose of a prescribed GLP-1 receptor agonist drug to coincide with the baseline visit of this study * Be randomly assigned to one of two groups (Group A will receive off-label injections of hyperdiluted CaHA at Month 0. Group B will receive on-label injections of CaHA after serving as a control group through Month 6) * Have clinical photos taken at each office visit to track progress
Primary Outcome
The investigators will look at changes in cheek volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking
Conditions Studied
Interventions
- DEVICE Hyperdiluted Calcium Hydroxylapatite
- DEVICE Calcium hydroxylapatite
- DEVICE Calcium hydroxylapatite with integral lidocaine
Study Locations (1)
California
- K. Kay Durairaj, MD, A Medical Corp. - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-02 |
| Est. Completion | 2027-09 |
| Phase | Phase 4 |
What NCT07419854 shows while recruiting
NCT07419854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Volume Loss (Soft Tissue Ptosis or Atrophy ) appearing as the primary indexed condition, and to 3 interventions - of which Hyperdiluted Calcium Hydroxylapatite is the first listed.
NCT07419854 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07419854 about?
NCT07419854 is a clinical study titled "Restoring Facial Volume After GLP-1 Weight Loss With Radiesse". The goal of this clinical trial is to evaluate the potential of Calcium Hydroxylapatite (CaHA) to restore facial volume and improve skin quality in patients with GLP-1 receptor agonist-associated facial volume loss. Participants will: * Schedule first dose of a prescribed GLP-1 receptor agonist dru...
What is the current status of trial NCT07419854?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2026-02. Estimated completion is 2027-09.
What conditions does trial NCT07419854 study?
This clinical trial studies the following conditions: Volume Loss (Soft Tissue Ptosis or Atrophy ).
What interventions are being tested in trial NCT07419854?
The interventions under investigation include: Hyperdiluted Calcium Hydroxylapatite (DEVICE), Calcium hydroxylapatite (DEVICE), Calcium hydroxylapatite with integral lidocaine (DEVICE).
Who is sponsoring clinical trial NCT07419854?
This trial is sponsored by Kalpna Kay Durairaj, MD, FACS, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07419854 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07419854's enrollment target sits among peer trials
48 1331st of 2000 higher than 654 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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