Recruiting
Phase 4

CaHA

Sponsor:

Kalpna Kay Durairaj, MD, FACS

Code:

NCT07419854

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy )

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Hyperdiluted Calcium Hydroxylapatite

Calcium hydroxylapatite

Calcium hydroxylapatite with integral lidocaine

Study Details

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

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy )

Study ID

NCT07419854

Start date

Feb 1, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Cheek Volume, as quantified by Quantificare's LifeViz Software [ Time Frame: Up to 6 months ]
  • Change in Jowl Volume, as quantified by Quantificare's LifeViz Software [ Time Frame: Up to 6 months ]
  • Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software [ Time Frame: Up to 6 months ]
  • Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software [ Time Frame: Up to 6 months ]
  • Body Mass Index (BMI) [ Time Frame: Up to 12 months ]
  • Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance [ Time Frame: Up to 6 months ]
  • Global Aesthetic Improvement Scale (GAIS) for Skin Quality [ Time Frame: Up to 6 months ]
  • Global Aesthetic Improvement Scale (GAIS) for Skin Radiance [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Kalpna K Durairaj, MD

6263167033drkay@beautybydrkay.com

Locations

K. Kay Durairaj, MD, A Medical Corp.

Recruiting

Pasadena, California, United States, 91105

Contacts

Kalpna K Durairaj, MD

8183167033drkay@beautybydrkay.com

Principal Investigator:

Kalpna K Durairaj, MD

More Information

Sponsor

Kalpna Kay Durairaj, MD, FACS

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Calcium Hydroxylapatite
  • Hyperdiluted Calcium Hydroxylapatite
  • Minimally invasive
  • GLP-1 Receptor Agonist
  • GLP-1
  • Volume loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Kalpna Kay Durairaj, MD, FACS on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.