Volume Loss (Soft Tissue Ptosis or Atrophy )Phase 4NCT07419854
Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
A Phase 4 study testing Hyperdiluted Calcium Hydroxylapatite, Calcium hydroxylapatite and Calcium hydroxylapatite with integral lidocaine in people with Volume Loss (Soft Tissue Ptosis or Atrophy ), run by Kalpna Kay Durairaj, MD, FACS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Volume Loss (Soft Tissue Ptosis or Atrophy )
- What is being tested?
- Hyperdiluted Calcium Hydroxylapatite, Calcium hydroxylapatite and Calcium hydroxylapatite with integral lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
K. Kay Durairaj, MD, A Medical Corp.
Pasadena, California, 91105
Kalpna K Durairaj, MD, 8183167033, drkay@beautybydrkay.com
Kalpna K Durairaj, MD
About this study
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
Read the 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 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).
- Being tested
- Hyperdiluted Calcium Hydroxylapatite, Calcium hydroxylapatite, Calcium hydroxylapatite with integral lidocaine
- Keywords
- Calcium Hydroxylapatite, Hyperdiluted Calcium Hydroxylapatite, Minimally invasive, GLP-1 Receptor Agonist, GLP-1, Volume loss
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperdiluted Calcium HydroxylapatiteDevice
Also called Radiesse, CaHA
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 hydroxylapatiteDevice
Also called Radiesse, CaHA
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 lidocaineDevice
Also called Radiesse (+), CaHA
Each syringe contains 1.5 cc of product and will be used as is to target the jawline and body of the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0 | Experimental | 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. Receives: Device: Hyperdiluted Calcium Hydroxylapatite |
| No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6 | Experimental | 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. Receives: Device: Calcium hydroxylapatite; Device: Calcium hydroxylapatite with integral lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 6 months
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- 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
Measured: 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
- 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
Measured: 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
- Mild folds
- Moderate folds
- Severe folds
- Very Severe folds
Measured: 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
- Mild lines
- Moderate lines
- Severe lines
- Very Severe lines
Measured: 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
- Mild downturn
- Moderate downturn
- Severe downturn
- Very Severe downturn
Measured: 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
- Mildly sunken lower cheek
- Moderately sunken lower cheek
- Severely sunken lower cheek
- Very severely sunken lower cheek
Measured: 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
- Mildly sunken upper cheek
- Moderately sunken upper cheek
- Severely sunken upper cheek
- Very severely sunken upper cheek
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Volume Loss (Soft Tissue Ptosis or Atrophy )Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kalpna Kay Durairaj, MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Responsible party
- Sponsor-investigator, Kalpna Kay Durairaj, MD, FACS, K. Kay Durairaj, MD, FACS, A Medical Corporation
- Investigators
- Kalpna K Durairaj, MD, Principal investigator, K. Kay Durairaj, MD, A Medical Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419854
- Sponsor's protocol ID
- RAD-VAR-US004
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with interest in utilizing calcium hydroxylapatite to treat/prevent GLP-1 receptor agonist-associated facial volume loss. Individual participant data that underlies the results reported in this article will be shared after de-identification. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Furthermore, the proposed use of trial IPD must be approved with an Independent Review Committee prior to any data sharing.
Publications
Casabona G, Pereira G. Microfocused Ultrasound with Visualization and Calcium Hydroxylapatite for Improving Skin Laxity and Cellulite Appearance. Plast Reconstr Surg Glob Open. 2017 Jul 25;5(7):e1388. doi: 10.1097/GOX.0000000000001388. eCollection 2017 Jul.
PubMed 28831339Yutskovskaya YA, Kogan EA. Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Decolletage:A Pilot Study. J Drugs Dermatol. 2017 Jan 1;16(1):68-74.
PubMed 28095536Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
PubMed 20480786Gonzalez N, Goldberg DJ. Evaluating the Effects of Injected Calcium Hydroxylapatite on Changes in Human Skin Elastin and Proteoglycan Formation. Dermatol Surg. 2019 Apr;45(4):547-551. doi: 10.1097/DSS.0000000000001809.
PubMed 30893178Marmur ES, Phelps R, Goldberg DJ. Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther. 2004 Dec;6(4):223-6. doi: 10.1080/147641704100003048.
PubMed 16020207Kadouch JA. Calcium hydroxylapatite: A review on safety and complications. J Cosmet Dermatol. 2017 Jun;16(2):152-161. doi: 10.1111/jocd.12326. Epub 2017 Mar 1.
PubMed 28247924Bass LS, Smith S, Busso M, McClaren M. Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthet Surg J. 2010 Mar;30(2):235-8. doi: 10.1177/1090820X10366549.
PubMed 20442101Chao YY, Kim JW, Kim J, Ko H, Goldie K. Hyperdilution of CaHA fillers for the improvement of age and hereditary volume deficits in East Asian patients. Clin Cosmet Investig Dermatol. 2018 Jul 16;11:357-363. doi: 10.2147/CCID.S159752. eCollection 2018.
PubMed 30038511Cogorno Wasylkowski V. Body vectoring technique with Radiesse((R)) for tightening of the abdomen, thighs, and brachial zone. Clin Cosmet Investig Dermatol. 2015 May 19;8:267-73. doi: 10.2147/CCID.S75631. eCollection 2015.
PubMed 26056483Emer J, Sundaram H. Aesthetic applications of calcium hydroxylapatite volumizing filler: an evidence-based review and discussion of current concepts: (part 1 of 2). J Drugs Dermatol. 2013 Dec;12(12):1345-54.
PubMed 24301235Lorenc ZP, Black JM, Cheung JS, Chiu A, Del Campo R, Durkin AJ, Graivier M, Green JB, Kwok GP, Marcus K, Rammos CB, Werschler WP. Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice. Aesthet Surg J. 2022 Jan 1;42(1):NP29-NP37. doi: 10.1093/asj/sjab269.
PubMed 34192299Breithaupt A, Fitzgerald R. Collagen Stimulators: Poly-L-Lactic Acid and Calcium Hydroxyl Apatite. Facial Plast Surg Clin North Am. 2015 Nov;23(4):459-69. doi: 10.1016/j.fsc.2015.07.007.
PubMed 26505542Goldman MP, Moradi A, Gold MH, Friedmann DP, Alizadeh K, Adelglass JM, Katz BE. Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial. Dermatol Surg. 2018 Jan;44(1):75-83. doi: 10.1097/DSS.0000000000001203.
PubMed 28562435Carruthers A, Liebeskind M, Carruthers J, Forster BB. Radiographic and computed tomographic studies of calcium hydroxylapatite for treatment of HIV-associated facial lipoatrophy and correction of nasolabial folds. Dermatol Surg. 2008 Jun;34 Suppl 1:S78-84. doi: 10.1111/j.1524-4725.2008.34247.x.
PubMed 18547186Silvers SL, Eviatar JA, Echavez MI, Pappas AL. Prospective, open-label, 18-month trial of calcium hydroxylapatite (Radiesse) for facial soft-tissue augmentation in patients with human immunodeficiency virus-associated lipoatrophy: one-year durability. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):34S-45S. doi: 10.1097/01.prs.0000234847.36020.52.
PubMed 16936543
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
- ClinicalTrials.gov ID
- NCT07419854
- Acronym / sponsor ID
- RAD-VAR-US004
- Keywords
- Calcium Hydroxylapatite, Hyperdiluted Calcium Hydroxylapatite, Minimally invasive, GLP-1 Receptor Agonist, GLP-1, Volume loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kalpna Kay Durairaj, MD, FACSUniversity, hospital or other
- Collaborators
- Merz Aesthetics Inc.
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0 | Experimental | Device: Hyperdiluted Calcium HydroxylapatiteSubjects 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. |
| No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6 | Experimental | Device: Calcium hydroxylapatite, Device: Calcium hydroxylapatite with integral lidocaineSubjects 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperdiluted Calcium HydroxylapatiteAlso: Radiesse, CaHAEach 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. | Device | Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0 |
| Calcium hydroxylapatiteAlso: Radiesse, CaHAEach 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. | Device | No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6 |
| Calcium hydroxylapatite with integral lidocaineAlso: Radiesse (+), CaHAEach syringe contains 1.5 cc of product and will be used as is to target the jawline and body of the mandible. | Device | No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6 |
Primary outcome
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.
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.
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.
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.
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.
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
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
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
16 secondary outcomes
Change in Cheek Volume, as quantified by Quantificare's LifeViz Software
Time frame: Up to 12 months
Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software
Time frame: Up to 12 months
Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software
Time frame: Up to 12 months
Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software
Time frame: Up to 12 months
Merz Cheek Fullness Assessment Scale
Time frame: Up to 12 months
Merz Jawline Assessment Scale
Time frame: Up to 12 months
Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation
Time frame: Up to 12 months
Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation
Time frame: Up to 12 months
Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation
Time frame: Up to 12 months
Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation
Time frame: Up to 12 months
Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation
Time frame: Up to 12 months
Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance
Time frame: Up to 12 months
Global Aesthetic Improvement Scale (GAIS) for Skin Quality
Time frame: Up to 12 months
Global Aesthetic Improvement Scale (GAIS) for Skin Radiance
Time frame: Up to 12 months
Psychosocial Questionnaires
Time frame: Up to 12 months
Patient Treatment Satisfaction
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 28831339Casabona G, Pereira G. Microfocused Ultrasound with Visualization and Calcium Hydroxylapatite for Improving Skin Laxity and Cellulite Appearance. Plast Reconstr Surg Glob Open. 2017 Jul 25;5(7):e1388. doi: 10.1097/GOX.0000000000001388. eCollection 2017 Jul.
- Background: PubMed 28095536Yutskovskaya YA, Kogan EA. Improved Neocollagenesis and Skin Mechanical Properties After Injection of Diluted Calcium Hydroxylapatite in the Neck and Decolletage:A Pilot Study. J Drugs Dermatol. 2017 Jan 1;16(1):68-74.
- Background: PubMed 20480786Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
- Background: PubMed 30893178Gonzalez N, Goldberg DJ. Evaluating the Effects of Injected Calcium Hydroxylapatite on Changes in Human Skin Elastin and Proteoglycan Formation. Dermatol Surg. 2019 Apr;45(4):547-551. doi: 10.1097/DSS.0000000000001809.
- Background: PubMed 16020207Marmur ES, Phelps R, Goldberg DJ. Clinical, histologic and electron microscopic findings after injection of a calcium hydroxylapatite filler. J Cosmet Laser Ther. 2004 Dec;6(4):223-6. doi: 10.1080/147641704100003048.
- Background: PubMed 28247924Kadouch JA. Calcium hydroxylapatite: A review on safety and complications. J Cosmet Dermatol. 2017 Jun;16(2):152-161. doi: 10.1111/jocd.12326. Epub 2017 Mar 1.
- Background: PubMed 20442101Bass LS, Smith S, Busso M, McClaren M. Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results. Aesthet Surg J. 2010 Mar;30(2):235-8. doi: 10.1177/1090820X10366549.
- Background: PubMed 30038511Chao YY, Kim JW, Kim J, Ko H, Goldie K. Hyperdilution of CaHA fillers for the improvement of age and hereditary volume deficits in East Asian patients. Clin Cosmet Investig Dermatol. 2018 Jul 16;11:357-363. doi: 10.2147/CCID.S159752. eCollection 2018.
- Background: PubMed 26056483Cogorno Wasylkowski V. Body vectoring technique with Radiesse((R)) for tightening of the abdomen, thighs, and brachial zone. Clin Cosmet Investig Dermatol. 2015 May 19;8:267-73. doi: 10.2147/CCID.S75631. eCollection 2015.
- Background: PubMed 24301235Emer J, Sundaram H. Aesthetic applications of calcium hydroxylapatite volumizing filler: an evidence-based review and discussion of current concepts: (part 1 of 2). J Drugs Dermatol. 2013 Dec;12(12):1345-54.
- Background: PubMed 34192299Lorenc ZP, Black JM, Cheung JS, Chiu A, Del Campo R, Durkin AJ, Graivier M, Green JB, Kwok GP, Marcus K, Rammos CB, Werschler WP. Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice. Aesthet Surg J. 2022 Jan 1;42(1):NP29-NP37. doi: 10.1093/asj/sjab269.
- Background: PubMed 26505542Breithaupt A, Fitzgerald R. Collagen Stimulators: Poly-L-Lactic Acid and Calcium Hydroxyl Apatite. Facial Plast Surg Clin North Am. 2015 Nov;23(4):459-69. doi: 10.1016/j.fsc.2015.07.007.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with interest in utilizing calcium hydroxylapatite to treat/prevent GLP-1 receptor agonist-associated facial volume loss. Individual participant data that underlies the results reported in this article will be shared after de-identification. Approval of the request and execution of all applicable agreements (e.g., a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Furthermore, the proposed use of trial IPD must be approved with an Independent Review Committee prior to any data sharing.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kalpna K Durairaj, MD principal investigator
K. Kay Durairaj, MD, A Medical Corp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperdiluted Calcium Hydroxylapatite, Calcium hydroxylapatite and Calcium hydroxylapatite with integral lidocaine in people with Volume Loss (Soft Tissue Ptosis or Atrophy ), run by Kalpna Kay Durairaj, MD, FACS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kalpna K Durairaj, MD (6263167033, drkay@beautybydrkay.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cheek Volume, as quantified by Quantificare's LifeViz Software (time frame: Up to 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419854, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.