Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07419854 for Volume Loss (Soft Tissue Ptosis or Atrophy ) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse Phase 4 48
Clinical Trial NCT07419854 is designed to study Treatment for Volume Loss (Soft Tissue Ptosis or Atrophy ). It is a Phase 4 interventional study that is recruiting, having started on February 1, 2026, with plans to enroll 48 participants. Led by Kalpna Kay Durairaj, MD, FACS, it is expected to complete by September 1, 2027. The latest data from ClinicalTrials.gov was last updated on February 19, 2026.
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 of...
Detailed 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 pre...
Show MoreOfficial Title
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
Conditions
Volume Loss (Soft Tissue Ptosis or Atrophy )Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- RAD-VAR-US004
NCT ID Number
Start Date (Actual)
2026-02
Last Update Posted
2026-02-19
Completion Date (Estimated)
2027-09
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Calcium Hydroxylapatite
Hyperdiluted Calcium Hydroxylapatite
Minimally invasive
GLP-1 Receptor Agonist
GLP-1
Volume loss
Hyperdiluted Calcium Hydroxylapatite
Minimally invasive
GLP-1 Receptor Agonist
GLP-1
Volume loss
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTreated 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. | 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. |
ExperimentalNo 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. | 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 Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Cheek Volume, as quantified by Quantificare's LifeViz Software | 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. | Up to 6 months |
Change in Jowl Volume, as quantified by Quantificare's LifeViz Software | 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. | Up to 6 months |
Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software | 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. | Up to 6 months |
Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software | 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. | Up to 6 months |
Body Mass Index (BMI) | 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. | Up to 12 months |
Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance | 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 | Up to 6 months |
Global Aesthetic Improvement Scale (GAIS) for Skin Quality | 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 | Up to 6 months |
Global Aesthetic Improvement Scale (GAIS) for Skin Radiance | 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 | Up to 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Cheek Volume, as quantified by Quantificare's LifeViz Software | 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. | Up to 12 months |
Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software | 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. | Up to 12 months |
Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software | 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. | Up to 12 months |
Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software | 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. | Up to 12 months |
Merz Cheek Fullness Assessment Scale | 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
1. Mildly Sunken Cheek: Mildly flattened cheek region, tear trough may be present
2. Moderately Sunken Cheek: Moderately sunken cheek, tear trough may be present
3. Severely Sunken Cheek: Severely sunken cheek with marked cheek volume loss, tear trough present
4. Very Severely Sunken Cheek: Very severely sunken cheek with extensive cheek volume loss, distinct tear trough | Up to 12 months |
Merz Jawline Assessment Scale | 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
1. 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
2. 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
3. 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
4. Extreme: Extreme disruption of jawline contour; extreme post-jowl and pre-jowl volume loss | Up to 12 months |
Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation | 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
1. Mild folds
2. Moderate folds
3. Severe folds
4. Very Severe folds | Up to 12 months |
Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation | 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
1. Mild lines
2. Moderate lines
3. Severe lines
4. Very Severe lines | Up to 12 months |
Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation | 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
1. Mild downturn
2. Moderate downturn
3. Severe downturn
4. Very Severe downturn | Up to 12 months |
Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation | 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
1. Mildly sunken lower cheek
2. Moderately sunken lower cheek
3. Severely sunken lower cheek
4. Very severely sunken lower cheek | Up to 12 months |
Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation | 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
1. Mildly sunken upper cheek
2. Moderately sunken upper cheek
3. Severely sunken upper cheek
4. Very severely sunken upper cheek | Up to 12 months |
Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance | 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 | Up to 12 months |
Global Aesthetic Improvement Scale (GAIS) for Skin Quality | 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 | Up to 12 months |
Global Aesthetic Improvement Scale (GAIS) for Skin Radiance | 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 | Up to 12 months |
Psychosocial Questionnaires | 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. | Up to 12 months |
Patient Treatment Satisfaction | 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. | Up to 12 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
21 Years
Eligible Sexes
All
- 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
- 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
Kalpna Kay Durairaj, MD, FACSMerz Aesthetics Inc.Study Responsible Party
Kalpna Kay Durairaj, MD, FACS, Sponsor-Investigator, Principal Investigator, K. Kay Durairaj, MD, FACS, A Medical Corporation
Study Central Contact
Contact: Kalpna K Durairaj, MD, 6263167033, [email protected]
1 Study Locations in 1 Countries
California
K. Kay Durairaj, MD, A Medical Corp., Pasadena, California, 91105, United States
Kalpna K Durairaj, MD, Contact, 8183167033, [email protected]
Kalpna K Durairaj, MD, Principal Investigator
Recruiting