Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

NCT07419854 | Recruiting Phase 4 FDA Device

• 1 other identifier: RAD-VAR-US004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Conditions

Volume Loss (Soft Tissue Ptosis or Atrophy )

Keywords

Calcium Hydroxylapatite; Hyperdiluted Calcium Hydroxylapatite; Minimally invasive; GLP-1 Receptor Agonist; GLP-1; Volume loss

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (16)

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

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

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

  Up to 12 months

• Merz Cheek Fullness Assessment Scale

  Up to 12 months

Study Arms (2)

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.

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.

Device: Calcium hydroxylapatite; Device: Calcium hydroxylapatite with integral lidocaine

Interventions

Hyperdiluted Calcium Hydroxylapatite DEVICE

Each syringe of CaHA contains 1.5 cc of product, and it will be diluted 1:2 with 0.5 cc of 1% Lidocaine and 2.5 cc of normal saline.

Also known as: Radiesse, CaHA

Treated with off-label injections of hyperdiluted Calcium Hydroxylapatite (CaHA) at Month 0

Calcium hydroxylapatite DEVICE

Each syringe of CaHA contains 1.5 cc of product, and 0.26 mL of 1% Lidocaine will be added to each syringe. This will be used to target facial folds and wrinkles.

Also known as: Radiesse, CaHA

No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6

Calcium hydroxylapatite with integral lidocaine DEVICE

Each syringe contains 1.5 cc of product and will be used as is to target the jawline and body of the mandible.

Also known as: Radiesse (+), CaHA

No treatment control through Month 6, on-label injections of calcium hydroxylapatite at Month 6

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kalpna Kay Durairaj, MD, FACS: lead
• Merz Aesthetics Inc.: collaborator

Study Sites (1)

K. Kay Durairaj, MD, A Medical Corp.

Pasadena, California, 91105, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 28831339 BACKGROUND

• 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.

  PMID: 28095536 BACKGROUND

• Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50.

  PMID: 20480786 BACKGROUND

• 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.

  PMID: 30893178 BACKGROUND

• 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.

  PMID: 16020207 BACKGROUND

• 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.

  PMID: 28247924 BACKGROUND

• 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.

  PMID: 20442101 BACKGROUND

• 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.

  PMID: 30038511 BACKGROUND

• 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.

  PMID: 26056483 BACKGROUND

• 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.

  PMID: 24301235 BACKGROUND

• 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.

  PMID: 34192299 BACKGROUND

• 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.

  PMID: 26505542 BACKGROUND

• 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.

  PMID: 28562435 BACKGROUND

• 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.

  PMID: 18547186 BACKGROUND

• 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.

  PMID: 16936543 BACKGROUND

• 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.

  PMID: 25610523 BACKGROUND

• 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.

  PMID: 30358631 BACKGROUND

• 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.

  PMID: 31044123 BACKGROUND

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kalpna K Durairaj, MD

  K. Kay Durairaj, MD, A Medical Corp.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalpna K Durairaj, MD

CONTACT

6263167033; drkay@beautybydrkay.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)