A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements

Alexiades, Macrene; Palm, Melanie D.; Kaufman‐Janette, Joely; Papel, Ira D.; Cross, Sarah J.; Abrams, Steve; Chawla, Smita

doi:10.1097/dss.0000000000003802

Cited by 5 publications

(1 citation statement)

References 25 publications

(42 reference statements)

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“…Although numerous biophysical techniques are utilized to measure different aspects of skin quality in studies, their lack of standardization and the need for costly technical equipment limit their practical use. 8-10 , 12 , 13 , 15 , 21 Although designed for objective measurements, instrumental tools are subject to operator-dependent data acquisition and interpretation, introducing subjectivity that, along with regular calibration needs, can lead to considerable intraobserver and interobserver variabilities. 22-25 Moreover, these techniques tend to focus on specific skin characteristics, such as hydration or elasticity, rather than providing an all-encompassing assessment of skin quality.…”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Composite Skin Quality Scale

Gold,

Lorenc,

Bass

et al. 2024

Aesthetic Surgery Journal Open Forum

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Background The increasing demand for skin quality interventions in aesthetic medicine underscores the necessity for objective, evidence-based assessment tools that may be used to evaluate novel interventions or devices. Objectives To develop and validate a 5-point photo-numeric rating scale for assessing overall skin quality, including radiance, color evenness, and smoothness. Methods The IBSA (Institut Biochimique SA) Composite Skin Quality Scale was developed and underwent live validation with 88 real-world patients, chosen to encompass a broad spectrum of skin qualities and Fitzpatrick skin types. Scale validation was performed by board-certified plastic surgeons and dermatologists over 2 rounds, 2 weeks apart. Reliability was assessed via intrarater and interrater agreements, utilizing weighted kappa statistics and intraclass correlation coefficient (ICC). The scale's ability to discern a clinically relevant 1-grade difference was evaluated with 72 photo pairs. Results Combined intrarater reliability results showed weighted kappa values of 0.812 (right side) and 0.815 (left side), and an ICC of 0.903 for both sides, indicating almost perfect agreement. Interrater reliability ranged from substantial to almost perfect, with kappa coefficients between 0.654 and 0.853, and ICCs from 0.657 to 0.855 across all rater pairs in both rounds. The ability to detect a clinically relevant 1-point difference using the scale was established. Conclusions Integrating various key aspects of skin quality, the IBSA Composite Skin Quality Scale is a clinically relevant and highly reliable tool, suitable for skin assessment in clinical studies of new aesthetic technologies and products.

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Section: Discussionmentioning

confidence: 99%

Development and Validation of a Composite Skin Quality Scale

Gold,

Lorenc,

Bass

et al. 2024

Aesthetic Surgery Journal Open Forum

View full text Add to dashboard Cite

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Improved Patient Satisfaction With Skin After Treatment of Cheek Skin Roughness and Fine Lines With VYC-12L: Participant-Reported Outcomes From a Prospective, Randomized Study

Chiu

Montes

Shamban³

et al. 2023

Aesthetic Surgery Journal

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Background VYC-12L is a hyaluronic acid filler to improve skin quality. A prospective study showed safety and effectiveness of VYC-12L for improving cheek skin smoothness and fine lines. Objectives To report participant-reported outcomes, subgroup analyses, and physician experience from the prospective study. Methods Adults with moderate-to-severe Allergan Cheek Smoothness Scale (ACSS) scores were randomized 2:1 to VYC-12L or control (no-treatment with optional treatment). Participant assessments included FACE-Q Satisfaction with Skin, FACE-Q Appraisal of Lines, natural look and feel, Global Aesthetic Improvement Scale (GAIS), and safety. Subgroup analyses examined ACSS responder rate (≥ 1-grade improvement from baseline to 1-month). Results FACE-Q Satisfaction with Skin overall mean scores improved from baseline to 1-month post-treatment by 32.0 and 1.4 in VYC-12L and control, respectively. FACE-Q Appraisal of Fine Lines overall mean scores improved from baseline to 1-month post-treatment by 23.3 and 0.4 in VYC-12L and control, respectively. Treated participants had high median scores (≥ 9.0) of natural look and feel of their cheek skin. GAIS responder rate was high at month 1 (85.5%; 95% CI, 79.3%-91.7%) and through month 6 (83.1%; 95% CI, 76.5%-89.7%). Mean participant-rated pain scores were low (< 3). The most common ISRs were redness, swelling, and lumps/bumps; most resolved within 3 days. Subgroup analyses showed significant differences in ACSS responder rate between VYC-12L and control 1-month post-treatment. Physician injectors reported that VYC-12L was easily injected at the superficial skin and integrated quickly. Conclusions VYC-12L treatment produced significant improvements in satisfaction with skin and cheek skin smoothness, as measured by participant-reported outcome measures.

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Decoding the Implications of Glucagon-like Peptide-1 Receptor Agonists on Accelerated Facial and Skin Aging

Ridha,

Fabi,

Zubar

et al. 2024

Aesthetic Surgery Journal

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Following the advent of glucagon-like peptide-1 receptor agonists (GLP1RA), subsequent unintended effects such as accelerated facial aging and altered skin health have been noted. This review delves deeper into the causative underlying mechanisms and provides insights into the intricate relationship between GLP-1RA, adipose tissue, and premature facial aging, thereby highlighting the need for a nuanced understanding of their effects on facial alterations and skin health. Studies exploring the potential effects of GLP-1RA on facial alterations and offering insights into the possible underlying mechanisms, causes and clinical implications were included. The accelerated facial aging and altered skin health observed in GLP-1RA patients appears to be multifactorial, involving loss of dermal and subcutaneous white adipose tissue, altered proliferation and differentiation of adipose-derived stem cells (ADSCs), and impacts on the production and secretion of hormonal and metabolic factors. These changes compromise the structural integrity and barrier function of the skin and may lead to diminished facial muscle mass, further exacerbating the appearance of aging. The insights presented call for a paradigm shift in the clinical management of facial changes induced by GLP-1RA, with a focus on treatment strategies aimed at targeting ADSC stimulation. These include autologous fat transfers to reintroduce cells rich in ADSCs for rejuvenation, composite fat grafting combining autologous fat with/without stromal vascular fraction, and the strategic use of soft tissue fillers for volume restoration and biostimulation. This review highlights the potential role of GLP-1RA in modulating adipose tissue dynamics, contributing to accelerated aging through metabolic, structural, and hormonal pathways.

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A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 5 publications

References 25 publications

Development and Validation of a Composite Skin Quality Scale

Development and Validation of a Composite Skin Quality Scale

Improved Patient Satisfaction With Skin After Treatment of Cheek Skin Roughness and Fine Lines With VYC-12L: Participant-Reported Outcomes From a Prospective, Randomized Study

Decoding the Implications of Glucagon-like Peptide-1 Receptor Agonists on Accelerated Facial and Skin Aging

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