NCT07419854

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Recruiting now Phase 4 Last updated 12 February 2026

What this trial tests

Phase 4 trial testing Hyperdiluted Calcium Hydroxylapatite in Volume Loss (Soft Tissue Ptosis or Atrophy ) in 48 participants. Currently enrolling.

Timeline

1 February 2026

Primary endpoint
1 August 2027

1 September 2027

Quick facts

Lead sponsor	Kalpna Kay Durairaj, MD, FACS
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	48
Start date	1 February 2026
Primary completion	1 August 2027
Estimated completion	1 September 2027
Sites	1 location across United States

Drugs / interventions tested

• Hyperdiluted Calcium Hydroxylapatite
• Calcium hydroxylapatite — full drug profile →
• Calcium hydroxylapatite with integral lidocaine

Conditions studied

• Volume Loss (Soft Tissue Ptosis or Atrophy ) — all drugs for Volume Loss (Soft Tissue Ptosis or Atrophy ) →

Sponsor

Kalpna Kay Durairaj, MD, FACS — full company profile →

Who can join

Adults 21 to 65, any sex, with Volume Loss (Soft Tissue Ptosis or Atrophy ). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Cheek Volume, as quantified by Quantificare's LifeViz Software
  Time frame: Up to 6 months
  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
• Change in Jowl Volume, as quantified by Quantificare's LifeViz Software
  Time frame: Up to 6 months
  The investigators will look at changes in jowl 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 c
• Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software
  Time frame: Up to 6 months
  The investigators will look at changes in nasolabial fold depth (in mm). 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 dif
• Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software
  Time frame: Up to 6 months
  The investigators will look at changes in marionette line depth (in mm). 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 dif
• Body Mass Index (BMI)
  Time frame: Up to 12 months
  The participant's weight (kilograms) and height (meters) will be collected to calculate individual BMI at each live assessment. Investigators will explore correlations between changes in BMI and facial volume loss over the period of the study.
• Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance
  Time frame: Up to 6 months
  Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Aesthetic appearance will be rated one of the five following options: * Worse: The appearance is worse than the original condition * No Change: The appearance is essentially the same as the original condition * Improved: Obvious improvement in appearan

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.