NCT07419854 Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
| NCT ID | NCT07419854 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kalpna Kay Durairaj, MD, FACS |
| Condition | Volume Loss (Soft Tissue Ptosis or Atrophy ) |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 48 participants in total. It began in 2026-02-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 pre-existing extreme lipoatrophy) and be willing to receive facial filler injections * Participants should be able to comply with all study visits and procedures up to 12 months * Participants must provide written informed consent, including consent for facial imaging Exclusion Criteria: * Participants with any prior facial cosmetic procedures that could confound results e.g. facial filler or fat transfer in the past 2 years; thread lifts or energy based device facial treatments in the last 1 year; microneedling, botulinum toxin treatment in the depressor anguli oris (DAO), or chemical peels in the last 4 months; or a history of surgical lifts and/or liposuction * Participants currently using a retinoid * Participants with active dermatologic conditions affecting the face (e.g. severe acne, psoriasis on face) or scars that would interfere with volume assessment * Participants with known allergies or hypersensitivity to CaHA or lidocaine (lidocaine allergy) * Those with a history of severe anaphylactic reactions requiring epinephrine (due to risk with injectables) * Those with uncontrolled diabetes or major comorbid conditions that would make participation unsafe (e.g. bleeding disorders that contraindicate injections, immunosuppression that raises infection risk, uncontrolled psychiatric illness such as body dysmorphic disorder) * Pregnant or breastfeeding women are excluded (GLP-1 therapies are contraindicated in pregnancy, and elective filler is avoided in pregnancy) * Women of childbearing potential must agree to use an effective contraceptive method during the study (though pregnancy during the short study window is unlikely, this is a precaution) * If a Participant becomes pregnant or initiates any new facial cosmetic treatment during the Study, they will be withdrawn * Participants planning bariatric surgery or other significant weight loss interventions (besides the GLP-1 medication) in the study period
Contact & Investigator
Kalpna K Durairaj, MD
PRINCIPAL INVESTIGATOR
K. Kay Durairaj, MD, A Medical Corp.
Frequently Asked Questions
Who can join the NCT07419854 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Volume Loss (Soft Tissue Ptosis or Atrophy ). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07419854 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07419854 currently recruiting?
Yes, NCT07419854 is actively recruiting participants. Contact the research team at drkay@beautybydrkay.com for enrollment information.
Where is the NCT07419854 trial being conducted?
This trial is being conducted at Pasadena, United States.
Who is sponsoring the NCT07419854 clinical trial?
NCT07419854 is sponsored by Kalpna Kay Durairaj, MD, FACS. The principal investigator is Kalpna K Durairaj, MD at K. Kay Durairaj, MD, A Medical Corp.. The trial plans to enroll 48 participants.