Calcium Hydroxylapatite for Soft Tissue Atrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Calcium Hydroxylapatite (CaHA) can restore facial volume and improve skin quality in individuals who lose facial volume after starting a new GLP-1 drug for weight loss or diabetes. Participants will be divided into two groups: one receives CaHA injections immediately, while the other waits six months before receiving them. The trial seeks individuals who are beginning GLP-1 therapy, aim to lose at least 20 pounds, and are comfortable with facial filler injections. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be starting GLP-1 therapy as part of the study. If you are using a retinoid, you cannot participate.
What is the safety track record for Radiesse?
Previous studies have shown that Calcium Hydroxylapatite (CaHA) is safe. Most patients report high satisfaction and experience only minor side effects. The most common side effect is small, temporary lumps at the injection site. For instance, one study found that nearly half of these lumps disappeared on their own.
CaHA is generally well-tolerated over time, with improvements in facial volume lasting up to 60 weeks. It has been successfully used to add volume under the skin, indicating its safety for facial use. Overall, the treatment is considered long-lasting and works well with human tissue, making it a reliable option for restoring facial volume.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using Radiesse, which contains calcium hydroxylapatite (CaHA), for soft tissue atrophy because it offers a unique approach compared to traditional fillers like hyaluronic acid. Unlike most fillers that primarily add volume, CaHA not only fills but also stimulates collagen production, potentially leading to longer-lasting improvements in skin texture and firmness. Additionally, the hyperdiluted form of CaHA allows for more precise contouring and subtle enhancements, offering a customizable treatment option for patients seeking natural-looking results.
What evidence suggests that Calcium Hydroxylapatite is effective for GLP-1 receptor agonist-associated facial volume loss?
Research has shown that Calcium Hydroxylapatite (CaHA), also known as Radiesse, effectively restores facial volume and improves skin quality. In this trial, one group of participants will receive off-label injections of hyperdiluted CaHA at Month 0, while another group will receive no treatment until Month 6, when they will receive on-label injections of CaHA. Studies have found that CaHA boosts collagen and elastin, which are crucial for maintaining firm and elastic skin. Specifically, it has improved areas like the lines from the nose to the mouth (nasolabial folds) and the jawline, with results lasting up to a year. CaHA also provides immediate volume replacement, making it a reliable choice for enhancing soft tissue. Overall, CaHA has a strong history of safety and effectiveness in facial treatments.56789
Who Is on the Research Team?
Kalpna K Durairaj, MD
Principal Investigator
K. Kay Durairaj, MD, A Medical Corp.
Are You a Good Fit for This Trial?
This trial is for adults aged 21-65 who are starting GLP-1 medications (like semaglutide or tirzepatide) for weight loss or diabetes, aiming to lose at least 20 pounds. Participants must have a BMI between 24 and 32, some facial fat, and be willing to get facial filler injections and have their photos taken.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Group A)
Group A receives off-label injections of hyperdiluted CaHA at Months 0 and 1
Treatment (Group B)
Group B serves as control through Month 6, then receives on-label injections of CaHA at Months 6 and 7
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Radiesse
Trial Overview
The study tests if calcium hydroxylapatite (Radiesse), given as either standard or diluted injections, can restore lost facial volume in people losing weight from GLP-1 drugs. Participants are randomly assigned to early treatment or delayed treatment after serving as controls.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Subjects will begin taking prescribed GLP-1 receptor agonist drugs to coincide with the baseline visit of this study. Subjects will receive 2 treatment sessions at Months 0 and 1. Live assessments will occur at Months 0, 1, 2, 4, 6, 8, 10, and 12. Approximately two syringes of CaHA will be injected per side of the face during each treatment session.
Subjects will begin taking prescribed GLP-1 receptor agonist drugs to coincide with the baseline visit of this study. Subjects will receive 2 treatment sessions at Months 6 and 7. Live assessments will occur at Months 0, 2, 4, 6, 7, 8, 10, and 12. Approximately three syringes of CaHA will be injected per side of the face during each treatment session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kalpna Kay Durairaj, MD, FACS
Lead Sponsor
Merz Aesthetics Inc.
Industry Sponsor
Citations
Prospective, open-label, 18-month trial of calcium ...
The objective was to evaluate the safety and effectiveness of soft-tissue augmentation of calcium hydroxylapatite (Radiesse) in patients with facial ...
The Role of Calcium Hydroxylapatite (Radiesse) as a ... - PMC
Radiesse treatment results in increases of collagen, elastin, vasculature, proteoglycans, and fibroblast populations via a cell-biomaterial–mediated ...
Restoring Facial Volume After GLP-1 Weight Loss With ...
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 ...
Calcium Hydroxylapatite (CaHA) and Aesthetic Outcomes
Current evidence suggests that CaHA injections improve aesthetic results, including facial areas, such as nasolabial folds and jawline, and hands, with high ...
Calcium Hydroxylapatite Over a Decade of Clinical ...
A multicenter, 47-month study of safety and efficacy of calcium hydroxylapatite for soft tissue augmentation of nasolabial folds and other areas of the face.
Calcium hydroxylapatite: A review on safety and ...
Based on the results in this study, CaHA appears to have a good safety profile. Nodules are by far the most common AE. Of the reported nodules, 49% occurred ...
Adverse Events and Satisfaction Outcomes with Calcium ...
The aim of this study was to systematically review the safety and effectiveness of the injectable biostimulators dermal fillers calcium hydroxyapatite (CaHA) ...
A multicenter, 47-month study of safety and efficacy ...
In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), ...
Long‐term duration and safety of Radiesse (+) for the ...
CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.