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Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

NCT07419854 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-02-19

No results posted yet for this study

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

Conditions

  • Volume Loss (Soft Tissue Ptosis or Atrophy )

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.

Sponsors & Collaborators

  • Merz Aesthetics Inc.

    collaborator INDUSTRY

  • Kalpna Kay Durairaj, MD, FACS

    lead OTHER

Principal Investigators

  • Kalpna K Durairaj, MD · K. Kay Durairaj, MD, A Medical Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-08-31
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07419854 on ClinicalTrials.gov