Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Conditions

• Volume Loss (Soft Tissue Ptosis or Atrophy )

Eligibility Criteria

Sex

ALL

Age

21 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Hyperdiluted Calcium Hydroxylapatite — DEVICE
  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.
• Calcium hydroxylapatite — DEVICE
  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.
• Calcium hydroxylapatite with integral lidocaine — DEVICE
  Each syringe contains 1.5 cc of product and will be used as is to target the jawline and body of the mandible.

Study Details

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 Dates

Start date

Feb 28, 2026

Status verified

Feb 2026

Primary completion

Aug 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

48 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0
  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.
• Experimental: No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6
  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.

Primary Outcome Measure

Change in Cheek Volume, as quantified by Quantificare's LifeViz Software [ Time Frame: Up to 6 months ]

Central Contacts

• Kalpna K Durairaj, MD
  6263167033
  [email protected]

Locations (1)

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