Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Kalpna Kay Durairaj, MD, FACS
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
Description
Forty-eight (48) subjects will be enrolled in this study, all of whom are initiating GLP-1 receptor agonist therapy for weight management. These 48 subjects will be split evenly between and randomly assigned to one of two groups. Group A will receive off-label injections of hyperdilute calcium hydroxylapatite diluted at a 1:2 ratio to target the sub-zygomatic fat pad, sub-malar fat pad, buccal fascial space, and prejowl sulcus. Group A will receive two treatment sessions at Months 0 and 1. Participants in Group A will be required to visit our office at Months 0, 1, 2, 4, 6, 8, 10, and 12. Gr…
Eligibility
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 21-65 who are initiating GLP-1 therapy (semaglutide, tirzepatide, or similar) for weight loss or diabetes-related weight management with targeted weight loss of 20 pounds or more * Participants must have a body mass index (BMI) meeting indications for GLP-1 therapy and within the range of 24-32 * Participants should be at the start of GLP-1 therapy (baseline visit scheduled at or within 1-2 weeks of first GLP-1 injection) so that baseline facial measurements represent their pre-weight-loss state * Participants must have noticeable facial subcutaneous fat (no…
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.
Location
- K. Kay Durairaj, MD, A Medical Corp.Pasadena, California