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RECRUITING
NCT07419854
PHASE4

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Sponsor: Kalpna Kay Durairaj, MD, FACS

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-02

Completion Date

2027-09

Last Updated

2026-02-19

Healthy Volunteers

No

Interventions

DEVICE

Hyperdiluted 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.

DEVICE

Calcium 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.

DEVICE

Calcium 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