RecruitingPhase 4NCT07419854

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Sponsor

Kalpna Kay Durairaj, MD, FACS

Enrollment

48 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy )

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

Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Calcium hydroxylapatite, a medical device called Calcium hydroxylapatite with integral lidocaine, and others for people with volume loss (soft tissue ptosis or atrophy ). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHyperdiluted Calcium Hydroxylapatite

Each syringe of CaHA contains 1.5 cc of product, and it will be diluted 1:2 with 0.5 cc of 1% Lidocaine and 2.5 cc of normal saline.

DEVICECalcium hydroxylapatite

Each syringe of CaHA contains 1.5 cc of product, and 0.26 mL of 1% Lidocaine will be added to each syringe. This will be used to target facial folds and wrinkles.

DEVICECalcium hydroxylapatite with integral lidocaine

Each syringe contains 1.5 cc of product and will be used as is to target the jawline and body of the mandible.

Locations(1)

K. Kay Durairaj, MD, A Medical Corp.

Pasadena, California, United States

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NCT07419854