Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merz Aesthetics Inc. | INDUSTRY |
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kalpna K Durairaj, MD | Contact | 6263167033 | drkay@beautybydrkay.com |
| Name | Affiliation | Role |
|---|---|---|
| Kalpna K Durairaj, MD | K. Kay Durairaj, MD, A Medical Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K. Kay Durairaj, MD, A Medical Corp. | Recruiting | Pasadena | California | 91105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28831339 | Background | 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. | |
| 28095536 | 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. |
Not provided
Not provided
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.
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 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.
Not provided
Not provided
| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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. |
|
|
| 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:
| 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:
| 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:
| Up to 6 months |
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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:
| 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:
| 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:
| 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 |
| 20480786 | Background | Lizzul PF, Narurkar VA. The role of calcium hydroxylapatite (Radiesse) in nonsurgical aesthetic rejuvenation. J Drugs Dermatol. 2010 May;9(5):446-50. |
| 30893178 | 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. |
| 16020207 | 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. |
| 28247924 | 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. |
| 20442101 | 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. |
| 30038511 | 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. |
| 26056483 | 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. |
| 24301235 | 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. |
| 34192299 | 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. |
| 26505542 | 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. |
| 28562435 | 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. |
| 18547186 | 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. |
| 16936543 | 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. |
| 25610523 | 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. |
| 30358631 | 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. |
| 31044123 | 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. |