Differentiating the Dilutional Rheology of Radiesse, Radiesse (+), and Radiesse With 0.26 mL of Lidocaine

IF 2.5 4区 医学 Q2 DERMATOLOGY Journal of Cosmetic Dermatology Pub Date : 2024-10-26 DOI:10.1111/jocd.16649
Alec D. McCarthy, Jani van Loghem, Radia El-Banna, Nadine Hagedorn
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However, these experiments were conducted using only Radiesse classic (CaHA), leading to an influx of inquiries regarding the rheological properties of both Radiesse (+), which contains 0.3% integral lidocaine (CaHA+), and Radiesse classic diluted with 0.26 mL of lidocaine (CaHA Mix Kit), all three of which bear US FDA approvals for injection [<span>5, 6</span>]. Therefore, we have repeated the rheological testing with CaHA(+) and CaHA Mix Kit with measurements taken at 1 Hz using the same methodology and same testing conditions reported in McCarthy et al. and compare the elastic modulus (G′), viscous modulus (G″), and tan(ẟ) with different dilutions of CaHA previously reported [<span>4</span>]. Each of these rheological properties provide insight into both the physical and clinical performance of viscoelastic gels [<span>7</span>]. Their summaries can be found in Table 1.</p><p>Summary values G′, G″, and tan(ẟ) are listed in Table 2. 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Clinically, CaHA(+) in its undiluted form may be exceptionally suited for deep injections and contouring, as the inclusion of lidocaine does not necessitate manual dilution, which is a standard practice when using CaHA as the addition of an FDA-approved 0.26 mL of lidocaine is generally added to mitigate injection site pain. The findings also suggest that CaHA Mix Kit has significantly lower direct volumization compared to undiluted CaHA and CaHA(+), but compared to other FDA approved hyaluronic acid fillers, would have one of the highest G′ values at 1 Hz [<span>8</span>]. For example, Restylane, Juvederm Voluma, Juvederm Ultra Plus, and Juvederm Ultra have G′ values of approximately 760, 580, 300, and 180 Pa when measured at 1 Hz [<span>9</span>]. 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Abstract

The rheological properties of injectable dermal fillers and biostimulators influence their clinical performance, cellular and tissue responses, and adverse event profiles and remain a crucial component in understanding product selection and placement [1-3]. In our previous publication titled “Dilutional Rheology of Radiesse: Implications for Regeneration and Vascular Safety”, we provide novel insight into the rheological properties of calcium hydroxylapatite-carboxymethylcellulose (CaHA-CMC; Radiesse, Merz Aesthetics) gels at various dilutions, revealing that CaHA-CMC is rheologically sensitive to even small aqueous dilutions [4]. However, these experiments were conducted using only Radiesse classic (CaHA), leading to an influx of inquiries regarding the rheological properties of both Radiesse (+), which contains 0.3% integral lidocaine (CaHA+), and Radiesse classic diluted with 0.26 mL of lidocaine (CaHA Mix Kit), all three of which bear US FDA approvals for injection [5, 6]. Therefore, we have repeated the rheological testing with CaHA(+) and CaHA Mix Kit with measurements taken at 1 Hz using the same methodology and same testing conditions reported in McCarthy et al. and compare the elastic modulus (G′), viscous modulus (G″), and tan(ẟ) with different dilutions of CaHA previously reported [4]. Each of these rheological properties provide insight into both the physical and clinical performance of viscoelastic gels [7]. Their summaries can be found in Table 1.

Summary values G′, G″, and tan(ẟ) are listed in Table 2. CaHA(+)'s G′ is approximately 18% lower than CaHA, but does not reach statistical significance (p = 0.0849), while CaHA Mix Kit is approximately 60% lower and does reach statistical significance (p < 0.0001) (Figure 1A). The G″ values of CaHA(+) and CaHA Mix Kit are both significantly lower than CaHA (p = 0.0003 and p < 0.0001, respectively) (Figure 1B). The tan(ẟ) of CaHA(+) is lower than CaHA, but not significantly (p = 0.9903) (Figure 1C). A summary of pairwise comparisons between each rheometric property and each CaHA product and dilution are given in the Supporting Information. These values suggest that CaHA(+) retains excellent volumizing properties. Clinically, CaHA(+) in its undiluted form may be exceptionally suited for deep injections and contouring, as the inclusion of lidocaine does not necessitate manual dilution, which is a standard practice when using CaHA as the addition of an FDA-approved 0.26 mL of lidocaine is generally added to mitigate injection site pain. The findings also suggest that CaHA Mix Kit has significantly lower direct volumization compared to undiluted CaHA and CaHA(+), but compared to other FDA approved hyaluronic acid fillers, would have one of the highest G′ values at 1 Hz [8]. For example, Restylane, Juvederm Voluma, Juvederm Ultra Plus, and Juvederm Ultra have G′ values of approximately 760, 580, 300, and 180 Pa when measured at 1 Hz [9]. Therefore, CaHA, CaHA(+), and CaHA Mix Kit should be regarded as high G′ fillers relative to commercially available HA fillers.

Overall, undiluted CaHA, undiluted CaHA(+), and CaHA Mix Kit possess high G′ values relative to previously reported HA fillers and exhibit predominantly solid-like behavior, making them uniquely suited for supraperiosteal injections, direct filling, and contouring [10, 11]. Aqueous dilutions of CaHA or CaHA(+) under 1:1 ratios retain direct filling, while dilutions greater than 1:1 function purely through biostimulation. The general understanding of these concepts is reflected in dilution schemes used in clinical practices and in the on-label dilutions (or lack thereof) by anatomical site, such as a 1:2 dilution for decolletage and undiluted for jawline [5, 12].

All authors have made substantial contributions to the conception and design, or acquisition of data, or analysis and interpretation of data, and have been involved in drafting the manuscript or revising it critically for important intellectual content. In addition, all authors have given final approval of the version to be published and agree to be accountable for all aspects of the work.

The authors have nothing to report.

Dr. McCarthy, Radia El-Banna, and Nadine Hagedorn are employed by Merz Aesthetics. Dr. van Loghem is a paid speaker, trainer, and researcher for Merz Aesthetics.

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区分 Radiesse、Radiesse (+) 和 Radiesse 与 0.26 mL 利多卡因的稀释流变学。
可注射真皮填充剂和生物刺激剂的流变特性影响其临床表现、细胞和组织反应以及不良事件概况,并且仍然是了解产品选择和放置的关键组成部分[1-3]。在我们之前发表的题为“Radiesse的稀释流变学:再生和血管安全的意义”的文章中,我们对羟基磷灰石钙-羧甲基纤维素(CaHA-CMC;Radiesse, Merz Aesthetics)在不同稀释度下的凝胶,表明CaHA-CMC对即使很小的水稀释度也具有流变敏感性。然而,这些实验仅使用Radiesse classic (CaHA)进行,导致大量关于Radiesse(+)(含有0.3%整体利多卡因(CaHA+))和Radiesse classic(稀释0.26 mL利多卡因(CaHA混合试剂盒))流变学特性的询问,这三种药物都获得了美国FDA的注射批准[5,6]。因此,我们用CaHA(+)和CaHA Mix Kit重复了流变学测试,使用McCarthy等人报道的相同方法和相同测试条件,在1hz下进行测量,并比较了不同稀释度的CaHA([4])的弹性模量(G′)、粘性模量(G″)和tan(ẟ)。这些流变性能为粘弹性凝胶[7]的物理和临床性能提供深入的了解。它们的摘要见表1。汇总值G′、G″和tan(ẟ)如表2所示。CaHA(+) s G′比CaHA低约18%,但未达到统计学意义(p = 0.0849),而CaHA Mix Kit低约60%,但达到统计学意义(p < 0.0001)(图1A)。CaHA(+)和CaHA Mix Kit的G″值均显著低于CaHA(p = 0.0003和p <; 0.0001)(图1B)。CaHA(+)的tan(ẟ)低于CaHA,但差异不显著(p = 0.9903)(图1C)。在辅助信息中给出了每种流变特性和每种CaHA产品和稀释度之间的两两比较的摘要。这些数值表明,CaHA(+)保持了良好的体积特性。在临床上,未稀释的CaHA(+)可能特别适合深度注射和轮廓,因为包含利多卡因不需要手动稀释,这是使用CaHA时的标准做法,添加fda批准的0.26 mL利多卡因通常用于减轻注射部位疼痛。研究结果还表明,与未稀释的CaHA和CaHA(+)相比,CaHA Mix Kit的直接体积显着降低,但与其他FDA批准的透明质酸填充剂相比,在1hz[8]时具有最高的G '值之一。例如,Restylane, Juvederm Voluma, Juvederm Ultra Plus和Juvederm Ultra在1 Hz[9]下测量时的G值约为760,580,300和180 Pa。因此,相对于市售的HA填充剂,CaHA、CaHA(+)和CaHA Mix Kit应被视为高G′填充剂。总的来说,与之前报道的HA填充剂相比,未稀释的CaHA、未稀释的CaHA(+)和CaHA Mix Kit具有较高的G′值,并表现出主要的固体样行为,使它们特别适合于骨上注射、直接填充和轮廓化[10,11]。CaHA或CaHA(+)在1:1比例下的水稀度保持直接填充,而大于1:1的稀度则完全通过生物刺激发挥作用。对这些概念的一般理解反映在临床实践中使用的稀释方案和按解剖部位进行的标签上稀释(或缺乏稀释)中,例如对衣领进行1:2稀释,对下颌进行未稀释[5,12]。所有作者都对数据的构思和设计、数据的获取、数据的分析和解释做出了实质性的贡献,并参与了手稿的起草或对重要知识内容的批判性修改。此外,所有作者都对即将出版的版本给予了最终批准,并同意对工作的各个方面负责。作者没有什么可报告的。McCarthy、Radia El-Banna和Nadine Hagedorn受雇于Merz Aesthetics。van Loghem博士是Merz Aesthetics的付费演讲者、培训师和研究员。
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来源期刊
CiteScore
4.30
自引率
13.00%
发文量
818
审稿时长
>12 weeks
期刊介绍: The Journal of Cosmetic Dermatology publishes high quality, peer-reviewed articles on all aspects of cosmetic dermatology with the aim to foster the highest standards of patient care in cosmetic dermatology. Published quarterly, the Journal of Cosmetic Dermatology facilitates continuing professional development and provides a forum for the exchange of scientific research and innovative techniques. The scope of coverage includes, but will not be limited to: healthy skin; skin maintenance; ageing skin; photodamage and photoprotection; rejuvenation; biochemistry, endocrinology and neuroimmunology of healthy skin; imaging; skin measurement; quality of life; skin types; sensitive skin; rosacea and acne; sebum; sweat; fat; phlebology; hair conservation, restoration and removal; nails and nail surgery; pigment; psychological and medicolegal issues; retinoids; cosmetic chemistry; dermopharmacy; cosmeceuticals; toiletries; striae; cellulite; cosmetic dermatological surgery; blepharoplasty; liposuction; surgical complications; botulinum; fillers, peels and dermabrasion; local and tumescent anaesthesia; electrosurgery; lasers, including laser physics, laser research and safety, vascular lasers, pigment lasers, hair removal lasers, tattoo removal lasers, resurfacing lasers, dermal remodelling lasers and laser complications.
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