Overview
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
Description
Forty-eight (48) subjects will be enrolled in this study, all of whom are initiating GLP-1 receptor agonist therapy for weight management. These 48 subjects will be split evenly between and randomly assigned to one of two groups.
Group A will receive off-label injections of hyperdilute calcium hydroxylapatite diluted at a 1:2 ratio to target the sub-zygomatic fat pad, sub-malar fat pad, buccal fascial space, and prejowl sulcus. Group A will receive two treatment sessions at Months 0 and 1. Participants in Group A will be required to visit our office at Months 0, 1, 2, 4, 6, 8, 10, and 12.
Group B serves as a control through Month 6 and crossover group at Month 6, receiving on-label injections of calcium hydroxylapatite. Treatment will target the jawline, body of the mandible, and facial folds and wrinkles. Group B will receive two treatment sessions at Months 6 and 7. Participants in Group B will be required to visit our office at Months 0, 2, 4, 6, 7, 8, 10, and 12.
Assessments will include 3D facial imaging (via the Quantificare Lifeviz Infinity Pro), AI-based imaging (via Perfect Corp's imaging software), and standardized clinical photography of the face (via a Nikon digital single lens reflex camera). All pictures will be stored via a HIPAA-compliant server. Weight and body mass index (BMI) will also be recorded at each visit to quantify each participant's weight loss trajectory. Participant journals prompt participants to self-report weight weekly.
The treating physician will use standardized scales for nasolabial folds, marionette lines, jawline, oral commissures, lower cheek fullness, upper cheek fullness, and cheek fullness at each visit to provide clinical ratings. The Global Aesthetic Improvement Scale (GAIS) will be used by the treating physician and subjects to rate aesthetic improvement at each time point after the initial treatment with calcium hydroxylapatite. Subjects will also rate their overall aesthetic improvement and treatment satisfaction according to a 5-point scale: (1) Extremely dissatisfied, (2) Dissatisfied, (3) Slightly satisfied, (4) Satisfied, (5) Extremely satisfied. Psychosocial questionnaires will be administered to participants to capture the psychological effect of natural facial wasting and volume restoration. Assessor blinding will be applied for subjective photo evaluations (e.g., a blinded panel comparing before/after photos).
Eligibility
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
