Restoring Facial Volume After GLP-1 Weight Loss With Radiesse

Обзор

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

Подробное описание

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).

Вмешательства

• Устройство 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.
• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Change in Cheek Volume, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 6 months]
• Change in Jowl Volume, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 6 months]
• Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 6 months]
• Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 6 months]
• Body Mass Index (BMI) [Срок оценки: Up to 12 months]
• Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance [Срок оценки: Up to 6 months]
• Global Aesthetic Improvement Scale (GAIS) for Skin Quality [Срок оценки: Up to 6 months]
• Global Aesthetic Improvement Scale (GAIS) for Skin Radiance [Срок оценки: Up to 6 months]

Вторичные конечные точки (12)

• Change in Cheek Volume, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 12 months]
• Changes in Jowl Volume, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 12 months]
• Change in Nasolabial Fold Depth, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 12 months]
• Change in Marionette Line Depth, as quantified by Quantificare's LifeViz Software [Срок оценки: Up to 12 months]
• Merz Cheek Fullness Assessment Scale [Срок оценки: Up to 12 months]
• Merz Jawline Assessment Scale [Срок оценки: Up to 12 months]
• Merz Aesthetics Nasolabial Fold (At Rest) Scale for Clinical Evaluation [Срок оценки: Up to 12 months]
• Merz Aesthetics Marionette Lines (At Rest) Scale for Clinical Evaluation [Срок оценки: Up to 12 months]
• Merz Aesthetics Oral Commissures (At Rest) Scale for Clinical Evaluation [Срок оценки: Up to 12 months]
• Merz Aesthetics Lower Cheek Fullness (At Rest) Scale for Clinical Evaluation [Срок оценки: Up to 12 months]
• Merz Aesthetics Upper Cheek Fullness (At Rest) Scale for Clinical Evaluation [Срок оценки: Up to 12 months]
• Global Aesthetic Improvement Scale (GAIS) for Global Facial Aesthetic Appearance [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• K. Kay Durairaj, MD, A Medical Corp. — Pasadena

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07419854 · RAD-VAR-US004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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