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

Study Overview

• Status: Recruiting
• Conditions: Volume Loss (Soft Tissue Ptosis or Atrophy )
• Intervention / Treatment: Device: Hyperdiluted Calcium Hydroxylapatite; Device: Calcium hydroxylapatite; Device: Calcium hydroxylapatite with integral lidocaine

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kalpna K Durairaj, MD; Phone Number: 6263167033; Email: drkay@beautybydrkay.com

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Recruiting
      • K. Kay Durairaj, MD, A Medical Corp.
      • Contact: Kalpna K Durairaj, MD; Phone Number: 8183167033; Email: drkay@beautybydrkay.com
      • Principal Investigator: Kalpna K Durairaj, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 21-65 who are initiating GLP-1 therapy (semaglutide, tirzepatide, or similar) for weight loss or diabetes-related weight management with targeted weight loss of 20 pounds or more
• Participants must have a body mass index (BMI) meeting indications for GLP-1 therapy and within the range of 24-32
• Participants should be at the start of GLP-1 therapy (baseline visit scheduled at or within 1-2 weeks of first GLP-1 injection) so that baseline facial measurements represent their pre-weight-loss state
• Participants must have noticeable facial subcutaneous fat (no pre-existing extreme lipoatrophy) and be willing to receive facial filler injections
• Participants should be able to comply with all study visits and procedures up to 12 months
• Participants must provide written informed consent, including consent for facial imaging

Exclusion Criteria:

• Participants with any prior facial cosmetic procedures that could confound results e.g. facial filler or fat transfer in the past 2 years; thread lifts or energy based device facial treatments in the last 1 year; microneedling, botulinum toxin treatment in the depressor anguli oris (DAO), or chemical peels in the last 4 months; or a history of surgical lifts and/or liposuction
• Participants currently using a retinoid
• Participants with active dermatologic conditions affecting the face (e.g. severe acne, psoriasis on face) or scars that would interfere with volume assessment
• Participants with known allergies or hypersensitivity to CaHA or lidocaine (lidocaine allergy)
• Those with a history of severe anaphylactic reactions requiring epinephrine (due to risk with injectables)
• Those with uncontrolled diabetes or major comorbid conditions that would make participation unsafe (e.g. bleeding disorders that contraindicate injections, immunosuppression that raises infection risk, uncontrolled psychiatric illness such as body dysmorphic disorder)
• Pregnant or breastfeeding women are excluded (GLP-1 therapies are contraindicated in pregnancy, and elective filler is avoided in pregnancy)
• Women of childbearing potential must agree to use an effective contraceptive method during the study (though pregnancy during the short study window is unlikely, this is a precaution)
• If a Participant becomes pregnant or initiates any new facial cosmetic treatment during the Study, they will be withdrawn
• Participants planning bariatric surgery or other significant weight loss interventions (besides the GLP-1 medication) in the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0; Subjects will begin taking prescribed GLP-1 receptor agonist drugs to coincide with the baseline visit of this study. Subjects will receive 2 treatment sessions at Months 0 and 1. Live assessments will occur at Months 0, 1, 2, 4, 6, 8, 10, and 12. Approximately two syringes of CaHA will be injected per side of the face during each treatment session.	Device: 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.; Other Names: Radiesse; CaHA
Experimental: No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6; Subjects will begin taking prescribed GLP-1 receptor agonist drugs to coincide with the baseline visit of this study. Subjects will receive 2 treatment sessions at Months 6 and 7. Live assessments will occur at Months 0, 2, 4, 6, 7, 8, 10, and 12. Approximately three syringes of CaHA will be injected per side of the face during each treatment session.	Device: 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.; Other Names: Radiesse; CaHA; Device: 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.; Other Names: CaHA; Radiesse (+)

What is the study measuring?

Primary 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

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 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; 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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Kalpna Kay Durairaj, MD, FACS
• Collaborators: Merz Aesthetics Inc.
• Investigators: Principal Investigator: Kalpna K Durairaj, MD, K. Kay Durairaj, MD, A Medical Corp.

Publications and helpful links

General Publications

• Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.
• 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.
• Yutskovskaya 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.
• Gonzalez 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.
• Marmur 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.
• Kadouch 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.
• Bass 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.
• Chao 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.
• Cogorno 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.
• Emer 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.
• Lorenc 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.
• Breithaupt 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.
• Goldman 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.
• Carruthers 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.
• Silvers 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.
• Loghem JV, Yutskovskaya YA, Philip Werschler W. Calcium hydroxylapatite: over a decade of clinical experience. J Clin Aesthet Dermatol. 2015 Jan;8(1):38-49.
• Goldie K, Peeters W, Alghoul M, Butterwick K, Casabona G, Chao YYY, Costa J, Eviatar J, Fabi SG, Lupo M, Sattler G, Waldorf H, Yutskovskaya Y, Lorenc P. Global Consensus Guidelines for the Injection of Diluted and Hyperdiluted Calcium Hydroxylapatite for Skin Tightening. Dermatol Surg. 2018 Nov;44 Suppl 1:S32-S41. doi: 10.1097/DSS.0000000000001685.
• de Almeida AT, Figueredo V, da Cunha ALG, Casabona G, Costa de Faria JR, Alves EV, Sato M, Branco A, Guarnieri C, Palermo E. Consensus Recommendations for the Use of Hyperdiluted Calcium Hydroxyapatite (Radiesse) as a Face and Body Biostimulatory Agent. Plast Reconstr Surg Glob Open. 2019 Mar 14;7(3):e2160. doi: 10.1097/GOX.0000000000002160. eCollection 2019 Mar.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: GLP-1; Minimally invasive; GLP-1 Receptor Agonist; Volume loss; Calcium Hydroxylapatite; Hyperdiluted Calcium Hydroxylapatite
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Atrophy
• Other Study ID Numbers: RAD-VAR-US004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available beginning 12 months and ending 24 months after article publication. Upon approval of a data sharing request, data will be accessible to researchers for up to 3 months.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in scientific research and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact research@beautybydrkay.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No