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NCT Number: NCT07419854

Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

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

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Key information

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy ) Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

K. Kay Durairaj, MD, A Medical Corp.

Pasadena, California, 91105, United States

Location status: Recruiting

Location contact

Kalpna K Durairaj, MD

CONTACT

[email protected]

8183167033

Kalpna K Durairaj, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Radiesse, CaHA

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.

Other names: Radiesse, CaHA

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.

Other names: Radiesse (+), CaHA

Primary outcomes

  1. Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 6 months

    The investigators will look at changes in cheek volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

  2. Change in Jowl Volume, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 6 months

    The investigators will look at changes in jowl volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

  3. Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 6 months

    The investigators will look at changes in nasolabial fold depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

  4. Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 6 months

    The investigators will look at changes in marionette line depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

  5. Body Mass Index (BMI)

    Time frame: Up to 12 months

    The participant's weight (kilograms) and height (meters) will be collected to calculate individual BMI at each live assessment. Investigators will explore correlations between changes in BMI and facial volume loss over the period of the study.

  6. Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

    Time frame: Up to 6 months

    Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Aesthetic appearance will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

  7. Global Aesthetic Improvement Scale (GAIS) for Skin Quality

    Time frame: Up to 6 months

    Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin quality will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

  8. Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

    Time frame: Up to 6 months

    Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin radiance will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

Secondary outcomes

  1. Change in Cheek Volume, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 12 months

    The investigators will look at changes in cheek volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

  2. Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 12 months

    The investigators will look at changes in jowl volume (in mL). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting or volume loss between visits.

  3. Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 12 months

    The investigators will look at changes in nasolabial fold depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

  4. Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software

    Time frame: Up to 12 months

    The investigators will look at changes in marionette line depth (in mm). The investigators will utilize the Quantificare LifeViz Infinity 3D imaging system at each visit to capture high-resolution, three-dimensional photographs of the participant's face from multiple angles, reconstructing a precise 3D model of the participant's facial surface. Using the system's software, volumetric and depth differences can be computed between time points by superimposing the 3D scans. The device's markerless tracking technology provides quantitative assessment of soft tissue changes, measuring the degree of tissue lifting between visits.

  5. Merz Cheek Fullness Assessment Scale

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies cheek fullness into 5 categories:

    (0) Full Cheek: Full cheek region, tear trough may be present

    • Mildly Sunken Cheek: Mildly flattened cheek region, tear trough may be present
    • Moderately Sunken Cheek: Moderately sunken cheek, tear trough may be present
    • Severely Sunken Cheek: Severely sunken cheek with marked cheek volume loss, tear trough present
    • Very Severely Sunken Cheek: Very severely sunken cheek with extensive cheek volume loss, distinct tear trough

  6. Merz Jawline Assessment Scale

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies jawline contour deficiencies into 5 categories:

    (0) None: Continuous jawline contour, no loss of jawline volume

    • Mild: Mild loss of jawline contour and continuity, mild loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present
    • Moderate: Moderate loss of jawline contour and continuity, moderate loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present
    • Severe: Severe loss of jawline contour and continuity, severe loss of volume in the post-jowl region, loss of volume in the pre-jowl region may be present
    • Extreme: Extreme disruption of jawline contour; extreme post-jowl and pre-jowl volume loss

  7. Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies nasolabial folds at rest into 5 categories:

    (0) No folds

    • Mild folds
    • Moderate folds
    • Severe folds
    • Very Severe folds

  8. Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies marionette lines at rest into 5 categories:

    (0) No lines

    • Mild lines
    • Moderate lines
    • Severe lines
    • Very Severe lines

  9. Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies oral commissures at rest into 5 categories:

    (0) No downturn

    • Mild downturn
    • Moderate downturn
    • Severe downturn
    • Very Severe downturn

  10. Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies lower cheek fullness at rest into 5 categories:

    (0) Full lower cheek

    • Mildly sunken lower cheek
    • Moderately sunken lower cheek
    • Severely sunken lower cheek
    • Very severely sunken lower cheek

  11. Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation

    Time frame: Up to 12 months

    The treating physician and blinded evaluators will rate the participant at each live assessment. The scale classifies upper cheek fullness at rest into 5 categories:

    (0) Full upper cheek

    • Mildly sunken upper cheek
    • Moderately sunken upper cheek
    • Severely sunken upper cheek
    • Very severely sunken upper cheek

  12. Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance

    Time frame: Up to 12 months

    Based on aesthetic appearance, qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Aesthetic appearance will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

  13. Global Aesthetic Improvement Scale (GAIS) for Skin Quality

    Time frame: Up to 12 months

    Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin quality will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

  14. Global Aesthetic Improvement Scale (GAIS) for Skin Radiance

    Time frame: Up to 12 months

    Qualitative success of treatment will be evaluated by the treating physician and blinded evaluators using the GAIS. Changes in skin radiance will be rated one of the five following options:

    • Worse: The appearance is worse than the original condition
    • No Change: The appearance is essentially the same as the original condition
    • Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated
    • Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject
    • Very Much Improved: Optimal cosmetic result in this subject

  15. Psychosocial Questionnaires

    Time frame: Up to 12 months

    For Group A, patient-reported questionnaires assess anticipated concern prior to treatment and perceived maintenance of facial appearance, psychosocial confidence, and satisfaction with the decision to treat early during the course of medication-associated weight loss. Questionnaires focus on preservation of facial appearance, confidence during weight loss, and perceived value of early intervention. For Group B, patient-reported questionnaires assess the psychosocial impact of facial volume loss and appearance-related changes occurring during weight loss prior to treatment, followed by satisfaction, perceived improvement, and psychosocial benefit after facial volume restoration. Participants will be given a list of statements about face and appearance. Participants will be asked to indicate level of agreement or disagreement with each statement using the following scale: (1) strongly disagree, (2) disagree, (3) neutral, (4) agree, or (5) strongly agree.

  16. Patient Treatment Satisfaction

    Time frame: Up to 12 months

    Participants will rate their satisfaction with the treatment at each treatment visit and at each subsequent live assessment. Patient satisfaction will be assessed using a 5-point scale: (1) extremely dissatisfied, (2) dissatisfied, (3) slightly satisfied, (4) satisfied, and (5) extremely satisfied.

Study contacts

Contact information is provided by the study sponsor or research team.

Kalpna K Durairaj, MD

CONTACT

[email protected]

6263167033

Sponsors and collaborators

Lead sponsor

Kalpna Kay Durairaj, MD, FACS

Other

Collaborators

  • Merz Aesthetics Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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