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1.
J Cosmet Dermatol ; 2024 Apr 10.
Artigo em Inglês | MEDLINE | ID: mdl-38600654

RESUMO

BACKGROUND: Pulsed-dye lasers (PDL) are one of the standard therapies for rosacea, but alternatives are needed. AIMS: To compare the efficacy and safety of the variable-sequenced, large-spot 532 nm KTP laser to the 595 nm PDL in treating rosacea. MATERIALS AND METHODS: A prospective, controlled, evaluator-blinded study. Patients were treated with either a KTP or PDL with 1-3 sessions at intervals of 6-8 weeks. A follow-up visit was scheduled on Week 6 post-treatment. Clinical outcome was assessed by computer-assisted analysis and by patients and two blinded dermatologists. Pain intensity during treatment and adverse events were documented. RESULTS: Forty-five patients (mean age 51 years) were allocated in a 2:1 ratio to either the KTP or PDL. Erythema in both treatment arms decreased significantly (p < 0.01). Clinical evaluation revealed high improvement. Mean pain intensity was significantly lower with the KTP (2.5/10) than with the PDL (4.1/10). Both lasers showed a good safety profile. Relevant purpura was only seen in the PDL group. CONCLUSIONS: Both the variable-sequenced, large-spot KTP and the PDL demonstrated comparable efficacy in treatment of rosacea. Regarding safety, the KTP exhibited fewer post-treatment reactions. The KTP might serve as a potential alternative to PDL in the treatment of rosacea.

2.
J Drugs Dermatol ; 23(1): 1337-1343, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38206152

RESUMO

BACKGROUND: The objective was to provide international recommendations on anti-aging dermocosmetics for clinical practice starting with essential ingredients for protection and repair before working up to advanced products for specific concerns.  Methods: Seven international experts reviewed 8 hypothetical case scenarios covering different ages, skin issues (eg, sensitivity, acne, melasma), and exposure to exposome factors for both sexes and all Fitzpatrick skin types (FST). The RAND/UCLA appropriateness method was used to obtain consensus. Seventeen key ingredients were rated on a scale from 1 (totally inappropriate) to 9 (totally appropriate). Statistical analysis, 2 meetings, and email discussions refined the recommendations. RESULTS: High-factor broad-spectrum sunscreen (ie, protects against ultraviolet [UV] A and B rays), niacinamide, and other topical antioxidants were recommended for all scenarios. Further discussions were required for other ingredients. Tinted sunscreen/iron oxide were recommended for all FST, although compliance may be sub-optimal for darker skin phototypes (IV-VI), if not cosmetically acceptable. Combining a facial foundation with broad-spectrum sunscreen was recommended for darker phototypes to obtain visible light protection closely matching diverse color tones. Retinols were not recommended as a first-line treatment for sensitive skin, especially FST V and VI, due to the risk of irritation. After ablative laser treatment, alpha hydroxy acids should be avoided or used with caution in FST IV to VI due to the risk of post-inflammatory hyperpigmentation. CONCLUSION: We describe a simple, practical tool for use in daily dermatology consultations for providing recommendations on anti-aging dermocosmetics to cover diverse and inclusive populations of patients, addressing all skin types and international needs.  J Drugs Dermatol. 2024;23(1):1337-1343.     doi:10.36849/JDD.7798.


Assuntos
Higiene da Pele , Protetores Solares , Feminino , Masculino , Humanos , Consenso , Pele , Envelhecimento
4.
Plast Reconstr Surg Glob Open ; 11(9): e5287, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37744770

RESUMO

Background: The objective of this investigation was to create and validate five-point photonumeric scales which assess static and dynamic forehead lines. Methods: Two different novel five-point photonumeric scales for the assessment of static and dynamic forehead lines were developed. Moreover, a photoguide was created, including subjects from both sexes, all age groups, and different Fitzpatrick skin types. A total of 11 raters from all over the world were involved in the digital validation, whereas four raters performed a live validation. Results: The Croma Static Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in both the digital and the live setting with inter-rater intraclass correlation coefficients of 0.86 [95% confidence interval (CI): 0.82-0.89] in the first digital rating and 0.82 [95% CI: 0.78-0.86] in the second digital rating. The Croma Dynamic Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in the digital setting with inter-rater intraclass correlation coefficients of 0.83 [95% CI: 0.79-0.86] in the first digital rating and 0.80 [95% CI: 0.75-0.84] in the second rating and almost substantial agreement in the live setting. Conclusions: The Croma Static Forehead Lines-Assessment Scale and the Croma Dynamic Forehead Lines-Assessment Scale have excellent inter and intra-rater agreements to be justifiably used in the clinical and study setting, both digitally and live across ethnic groups.

5.
Aesthet Surg J ; 43(11): 1347-1356, 2023 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-37052953

RESUMO

BACKGROUND: The use of validated scales is still considered the gold standard for evaluating the severity of an aesthetic facial condition. OBJECTIVES: The aim of this investigation was to create and validate 5-point photonumeric scales for the assessment of perioral lines and marionette lines. METHODS: A medical team created 2 different novel 5-point photonumeric scales for the assessment of perioral lines and marionette lines. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: For the Croma Static Perioral Lines-Assessment Scale, the digital interrater intraclass correlation coefficients (ICCs) were 0.88 (95% CI, 0.85-0.91) in the first rating and 0.87 (95% CI, 0.83-0.90) in the second rating. The digital intrarater ICCs were 0.90 (95% CI, 0.87-0.92). In the live rating, the interrater ICCs were 0.89 (95% CI, 0.85-0.93) in the first rating and 0.91 (95% CI, 0.87-0.93) in the second rating with an intrarater ICC of 0.91 (95% CI, 0.88-0.95). For the Croma Marionette Lines-Assessment Scale, the digital rating interrater ICCs were 0.85 (95% CI, 0.81-0.89) in the first rating and 0.87 (95% CI, 0.84-0.90) in the second rating with an intrarater ICC of 0.89 (95% CI, 0.88-0.91). In the live rating, the interrater ICCs were 0.73 (95% CI, 0.54-0.83) in the first rating and 0.79 (95% CI, 0.65-0.87) in the second rating with an intrarater ICC of 0.88 (95% CI, 0.83-0.94). CONCLUSIONS: The Croma Static Perioral Lines-Assessment Scale and the Croma Marionette Lines-Assessment Scale have exceptional inter- and intrarater agreements that justify their use in clinical and study settings for all ethnic groups.


Assuntos
Face , Fotografação , Humanos , Reprodutibilidade dos Testes , Estética , Variações Dependentes do Observador
6.
Aesthet Surg J ; 43(7): NP560-NP572, 2023 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-36840504

RESUMO

BACKGROUND: There is a scarcity of scales that assess platysmal bands, wrinkles in the décolleté, and horizontal neck lines in the digital and live setting. OBJECTIVES: The objective of this investigation was to create and validate 5-point photonumeric scales that assess horizontal neck lines, platysmal bands, and wrinkles in the décolleté. METHODS: A medical team created 3 different novel 5-point photonumeric scales for the assessment of horizontal neck lines, platysmal bands, and décolleté wrinkling. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: The Croma (Leobendorf, Austria) Horizontal Neck Lines Assessment Scale showed substantial interrater agreement and almost perfect intrarater agreement in the digital and live validations, respectively. The Croma Platysmal Bands Assessment Scale showed substantial intrarater agreement in both digital and live validations. For the décolleté, a static scale and a dynamic scale were created and validated. The Croma Static Décolleté Wrinkles Assessment Scale showed substantial and almost perfect interrater agreement in the digital and live validations, respectively, and the intrarater agreement in both was almost perfect. The Croma Dynamic Décolleté Wrinkles Assessment Scale showed almost perfect agreement in both validation settings for both interrater and intrarater measures. CONCLUSIONS: The Croma Horizontal Neck Lines Assessment Scale and the Croma Static and Dynamic Décolleté Wrinkles Assessment Scales have sufficient interrater and intrarater agreement for justifiable use in clinical and research settings.


Assuntos
Envelhecimento da Pele , Humanos , Reprodutibilidade dos Testes , Pescoço , Variações Dependentes do Observador
8.
J Clin Aesthet Dermatol ; 15(6): 10-21, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35783570

RESUMO

Objective: We sought to examine the current skin quality trends and gaps in clinical practice in the Asia Pacific region and develop a practical guide to improve skin quality. Methods: Medical practitioners from 11 countries in the Asia Pacific region completed an online survey on current trends in skin quality treatment. A panel of 12 leading experts convened for a virtual meeting to develop a practical guide for skin quality improvement. Results: A total of 153 practitioners completed the survey. The four most common skin quality issues were uneven skin tone, skin surface unevenness, skin laxity, and sebaceous gland hyperactivity and enlarged pores. Most practitioners reported using a combination of treatment modalities for each skin quality issue. It was also observed that each treatment modality could be used to treat several skin quality issues. A multimodal approach targeting different interrelated issues across the tissue planes was recommended for balanced results. The panel developed a practical guide for the appropriate combinations and sequence of treatments, and created treatment protocols for specific skin quality outcome goals. The guide employed an "inside-out" approach, treating the deeper tissue planes prior to the superficial layers to achieve harmonious results. Limitations: Future studies are needed to support the recommended treatment protocols for skin quality improvement. Conclusion: These findings provide valuable insights on current skin quality trends and gaps in clinical practice. The practical guide provides a framework for practitioners to customize their treatment plan according to each patient's needs.

9.
Clin Cosmet Investig Dermatol ; 15: 1157-1173, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35784268

RESUMO

Background: The "Inflammation Theory of Ageing" identifies pro-inflammatory cytokines and oxidative damage as one cause of cellular and mitochondrial deterioration and aging. Cell-free blood cell secretome (BCS) also known as autologous conditioned serum (ACS) has shown anti-inflammatory and regenerative mode of action in musculoskeletal disorders and radicular compression. Aim: To confirm that BCS can improve signs of skin aging from a previous study in a multi-center setting. Methods: Prospective, one-armed, multi-center interventional therapeutic study. Ninety-five women with skin firmness loss were treated with four intra-dermal injection sessions in both cheeks at 0, 2, 4 and 6 weeks. BCS was processed with Exokine® medical device according to manufacturer's instructions. Primary endpoints were cutometric R0 and R3 at 12 and 24 weeks. GAIS, FACE-QTM, Patient Attractivity Self-Assessment and safety were evaluated. Results: Mean skin firmness (R0) improved significantly from baseline 0.40 mm to 0.38 mm at week 12 and to 0.36 mm at week 24. Mean skin tiring (R3) improved significantly from baseline 0.45 mm to 0.42 mm at week 12 and to 0.40 at week 24. FACE-QTM "Satisfaction with Skin" significantly improved from baseline to weeks 12, 24 and 48. So did "Satisfaction with Facial Appearance" and "Psychological and Social Function". "Satisfaction with Decision" and "Satisfaction with Outcome" were stable at week 24 and 48. At week 48 patients assessed their age 1.68 years younger vs Baseline. FACE-QTM aging appraisal improves from Baseline 52.94 to 65.23 at week 48. GAIS, by both physicians and patients, confirm improvement of skin. Conclusion: For up to 48 weeks four intra-dermal injections with cell-free BCS increase facial skin firmness and resilience to tiring and patients' satisfaction with their facial appearance and skin. Patients perceive their face as younger. BCS has the ability to sustainably rejuvenate facial skin safely. Study Registration: Registration on German clinical trials register: DRKS00013014.

10.
Skin Res Technol ; 28(4): 633-642, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35643988

RESUMO

BACKGROUND: Skin quality improvement with hyaluronic acid microinjections is increasing as a clinical treatment indication and as a scientific issue. This present study assessed changes in biomechanical viscoelastic skin properties after microinjections with the skin quality booster CPM-HA20G (Belotero Revive). MATERIALS AND METHODS: Fifteen subjects have been randomized in a 2:1 ratio to receive either three treatments (total 3 ml per side) or a single-dose treatment (total 1.5 ml per side) with CPM-HA20G at dermal level into the lower cheeks via microinjections. Treatments were provided 4 weeks apart. Biophysical measurements were performed describing the viscoelastic skin properties and the underlying skin structure. The measurements were performed before injection (week 0) and on follow-up visits 4, 8, 16, 24, and 36 weeks after the last injection treatment. RESULTS: One (p = 0.028) as well as three (p = 0.003) consecutive treatments with CPM-HA20G improved statistically significant skin firmness (R0). For the multiple-treatment group improved significant differences were observed for skin fatigue (R3; p = 0.007) and skin density (p = 0.017) with stable skin thickness levels (p > 0.05), too. There were zero-to-weak correlations between skin thickness and biomechanical skin properties (R0, rs  = 0.084; R3, rs  = 0.093). CONCLUSION: Overall, microinjections with CPM-HA20G improved biomechanical viscoelastic skin properties with a stronger and more pronounced effect in the multiple-treatment group. The observed changes may explain some of the skin quality improvements observed after treatment with CPM-HA20G.


Assuntos
Técnicas Cosméticas , Envelhecimento da Pele , Glicerol , Humanos , Ácido Hialurônico/química , Microinjeções , Pele
11.
J Drugs Dermatol ; 21(5): 481-487, 2022 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-35533030

RESUMO

BACKGROUND: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. METHODS: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. RESULTS: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CONCLUSION: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Cálcio , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Durapatita/efeitos adversos , Humanos , Ácido Hialurônico , Lidocaína/efeitos adversos , Sulco Nasogeniano , Resultado do Tratamento
12.
J Cosmet Dermatol ; 21(3): 933-939, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35034418

RESUMO

OBJECTIVE: Quantifying the degree of dorsal hand atrophy is a challenging endeavor, but often necessary, in both the clinical and the research setting. The aim of this investigation was to create and consecutively validate a 5-point photonumeric scale for assessment of dorsal hand atrophy. MATERIAL AND METHODS: A medical team created a novel 5-point photonumeric scale. Twelve international raters were involved in the digital validation, while five raters performed a live validation. RESULTS: For the digital validation of the Croma Hand Atrophy Assessment Scale, a total of 72 subjects (58 females, 14 males) with a mean age of 43.0 ± 14.4 years [18-73 years] were assessed. For the live validation, 88 subjects (73 females, 15 males) with a mean age of 45.0 ± 14.1 years [20-73 years] were rated. The results revealed almost perfect intra-rater (ICC: 0.90 [95% CI: 0.88-0.92]) and inter-rater agreements (ICC: 0.85 [95% CI: 0.81-0.89] and 0.86 [95% CI:0.82-0.89]) in the digital validation and substantial intra-rater (ICC: 0.79 [95% CI: 0.75-0.82]) and inter-rater agreements (ICC: 0.75 [95% CI: 0.68-0.81] and ICC: 0.67 [95% CI: 0.54-0.77]) in the live validation. CONCLUSION: The created scale to assess dorsal hand atrophy has been shown to provide substantial-to-almost perfect agreement in the digital and live validation cycles and reached comparable intra-rater and inter-rater agreement to already published and validated scales. It is expected that the created scale will help physicians and researchers in the assessment of hand atrophy in the clinical and research setting in the future.


Assuntos
Reprodutibilidade dos Testes , Adulto , Atrofia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador
13.
J Cosmet Dermatol ; 21(1): 149-157, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34806283

RESUMO

BACKGROUND: The clinical indications, applications, and effect of the injectable hyaluronic acid range skin quality boosters (SQBs) are different than those of filler products. Material properties are increasingly being discussed for differentiation and in connection with clinical effects and esthetic indications. AIMS: The aim of this study is to evaluate whether SQB products can be differentiated from filler products by their physicochemical material properties. MATERIAL AND METHODS: Physicochemical properties (extrusion force, swelling degree, rheology, and cohesivity) of two SQBs (BELR , JUVVE ) were compared with those of fillers (BELB , JUVVT ) using the same manufacturing technology. RESULTS: Cohesivity was almost equal for SQBs and fillers. Few statistically significant differences in physicochemical properties were found. Properties of SQBs differed from fillers mainly in their delta of rheological properties and extrusion force. CONCLUSION: In this study, physicochemical differences between SQB and filler were determined and described, supporting the presence of two categories and their different clinical indications and applications.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Ácido Hialurônico , Reologia
14.
J Cosmet Dermatol ; 21(1): 158-166, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34865301

RESUMO

OBJECTIVE: The objective of this investigation was to create and validate 5-point photonumeric scales for the assessment of dynamic crow's feet, static crow's feet, and infraorbital hollows. MATERIAL AND METHODS: Three novel 5-point photonumeric scales were created by a medical team. A total of 12 raters from all over the world performed a digital validation, and a total of 5 raters a live validation of the created scale. RESULTS: The statistical analysis revealed almost perfect intra-rater and inter-rater reliability in the digital validation of the scales for the assessment of static and dynamic crow's feet as well as infraorbital hollows. In the live validation, both crow's feet scales showed almost perfect intra-rater reliability, while the Croma Infraorbital Hollow Assessment Scale showed substantial intra-rater reliability. Inter-rater reliability was substantial for all three scales in the live validation. All three scales, the Croma Dynamic Crow's Feet Assessment Scale, Croma Static Crow's Feet Assessment Scale, and Croma Infraorbital Hollow Assessment Scale, were validated digitally and in a live setting. CONCLUSION: The created scales to assess infraorbital hollowing, dynamic and static crow's feet have been shown to provide substantial to almost perfect agreement in the digital and live validation and can thus be considered as helpful tools in the clinical and research setting. While technical methods and appliances to assess the degrees of severity of age-dependent features are advancing, validated scales are of great importance due to their ease of use and, as shown by the validations, reliability, and reproducibility.


Assuntos
Envelhecimento da Pele , Face , Humanos , Reprodutibilidade dos Testes
15.
J Drugs Dermatol ; 20(10): 1052-1060, 2021 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-34636520

RESUMO

BACKGROUND: To further explore clinical trial results indicating increasing doses of botulinum toxin A prolong duration of effect, a 2-stage, phase 2, randomized, double-blind study investigated the duration of effect and safety of incobotulinumtoxinA (INCO; Xeomin®, Bocouture®) doses higher than the US Food and Drug Administration-approved 20 units (U) for glabellar frown lines (GFL). The stage 1 primary efficacy and safety results were reported previously. Here, we report the results of the final analysis (stage 1 and 2), including primary and secondary efficacy and safety endpoints. METHODS: A total of 241 subjects with moderate-to-severe GFL were randomized to receive a single treatment with 20 (N=61), 50 (N=60), 75 (N=61), or 100U (N=59) INCO. The primary efficacy endpoint was duration of ≥ 1-point improvement from baseline assessed by investigator at maximum frown on the Facial Wrinkle Scale. RESULTS: The median duration of effect was 175 days for the 20U group (95% CI 142, 185), 185 days for the 50U group (95% CI 182, 205), 210 days for the 75U group (95% CI 182, 217), and 215 days for the 100U group (95% CI 183, 237). The incidence of treatment-related adverse events was low across all doses and there were no treatment-related serious adverse events. CONCLUSIONS: These results demonstrate that all INCO doses were well tolerated, consistent with the known safety profile of 20U, and increasing dose prolongs the duration of effect for GFL. J Drugs Dermatol. 2021;20(10):1052-1060. doi:10.36849/JDD.6377THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.


Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Fármacos Neuromusculares/efeitos adversos , Resultado do Tratamento
16.
Clin Cosmet Investig Dermatol ; 14: 1175-1199, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34526796

RESUMO

BACKGROUND: As the treatment indications for the Cohesive Polydensified Matrix® hyaluronic acid (CPM-HA) portfolio continue to expand and diversify, injectors new to the range or those who are expanding the treatments they offer may be unsure of the optimal product and injection technique for specific facial areas. Each product in the CPM-HA portfolio has been intentionally designed to provide the best physical properties for a specific indication and target tissue. This document has been developed to provide a comprehensive, one-stop reference for clinicians using the portfolio. METHODS: An international panel of experts in the field of aesthetic medicine convened to develop guidelines on effective and safe injection technique when performing treatments with the CPM-HA range of soft-tissue fillers. RESULTS: Consensus members considered treatment indications in the upper, middle and lower face. Landmark deficiencies and anatomical considerations are described for each indication and consensus recommendations provided on the optimal product, injection depth and treatment technique. This is supplemented by the experts advice on avoidance of complications. Throughout, an evidence-based approach to selection of products and injection techniques is provided. The result is a fully tailored approach to a range of indications covering the full portfolio of CPM-HA products, including the newest addition for skin revitalization. CONCLUSION: The recommendations in this consensus document are provided to assist clinicians in the selection of CPM-HA products, administration techniques and depths of injection with the aim of providing seamless and natural treatment results, enhanced safety and patient satisfaction.

17.
Dermatol Surg ; 47(10): 1359-1364, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34417392

RESUMO

BACKGROUND: Facial aging is characterized by volume loss and progressive hollowing of temples and cheeks. Biodegradable filler materials are preferred over nonabsorbable materials; of these, hyaluronic acid (HA) fillers are the most often used because of their favorable effectiveness and safety profile. OBJECTIVE: To confirm the safety and effectiveness of Cohesive Polydensified Matrix (CPM)-HA26 gel in the treatment of volume deficiency. METHODS: Subjects received up to 2 treatments in the temples and/or cheeks. A blinded investigator assessed improvement according to the Merz Temple Volume Scale (MTVS) and Merz Cheek Fullness Assessment Scale (MCFAS). Subjects were followed for 48 weeks after the last treatment. RESULTS: In total, 87 healthy subjects were enrolled. The proportion of subjects achieving at least a 1-grade improvement on MTVS and/or MCFAS was above 70% for each (MTVS: Weeks 4, 24, and 48 = 95.4%, 94.2%, and 77.0%; MCFAS: Weeks 4, 24, and 48 = 92.3%, 83.1%, and 71.8%). Based on MTVS and MCFAS scores at Visit 5, improvement remained visible at up to 48 weeks. No treatment-related serious AEs occurred. CONCLUSION: CPM-HA26 demonstrated both a favorable safety and effectiveness profile, with improvement in facial volume evident for up to 48 weeks. It was well tolerated and had a positive, long-lasting effect.


Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico/efeitos adversos , Adulto , Envelhecimento , Bochecha , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/química , Feminino , Seguimentos , Voluntários Saudáveis , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/química , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
18.
J Drugs Dermatol ; 20(6): 682-688, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-34076388

RESUMO

BACKGROUND: Blood Cell Secretome, BCS (also Autologous Conditioned Serum, ACS) is efficacious in treatment of musculoskeletal disorders. It contains inflammation resolving cytokines, growth factors, exosomes, and lipid mediators. Skin aging is associated with reduced TGF-ß signaling and collagen synthesis and chronic (sub-acute) inflammation, among other factors. Pre-clinically, BCS counteracts these mechanisms, suggesting it as a treatment against cutaneous aging. OBJECTIVE: This 24-week study evaluated the effects of deep dermal to immediate sub-dermal micropuncture injections of cell-free BCS in patients with age-related reduced facial skin elasticity. METHODS: In this prospective, single-armed, mono-center study, 21 women underwent 4 BCS treatment sessions over 12 weeks with follow-up at 24 weeks. The primary endpoint was skin elasticity measured by cutometry. Secondary endpoints were safety, skin hydration, and aesthetic assessments using global aesthetic improvement scale. RESULTS: Skin firmness increased significantly between baseline and 12 weeks (P<0.001) and further increased by 24 weeks (P<0.001). Skin tiring was congruently reduced (P<0.001). Skin hydration and aesthetic ratings improved significantly. No BCS-related adverse reactions occurred. CONCLUSION: BCS treatment resulted in increased firmness and hydration, usually attributed to younger skin. BCS is potentially the first cell-free autologous therapy for skin rejuvenation derived from patients’ own blood. J Drugs Dermatol. 2021;20(6):682-688. doi:10.36849/JDD.5018.


Assuntos
Envelhecimento da Pele , Células Sanguíneas , Elasticidade , Feminino , Humanos , Estudos Prospectivos , Rejuvenescimento
19.
Clin Cosmet Investig Dermatol ; 14: 643-654, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34163203

RESUMO

INTRODUCTION: Skin quality is an important component of human attractiveness. To date, there are no standardized criteria for good skin quality. To establish a consensus for good skin quality parameters and measurement and treatment options, a virtual skin quality advisory board consisting of a global panel of highly experienced aesthetic dermatologists/aesthetic physicians was convened. METHODS: A total of 10 dermatologists/aesthetic physicians served on the advisory board. A modified version of the Delphi method was used to arrive at consensus. Members accessed an online platform to review statements on skin quality criteria from their peers, including treatment and measurement options, and voted to indicate whether they agreed or disagreed. Statements that did not have agreement were modified and the members voted again. Consensus was defined as: strong consensus = greater than 95% agreement; consensus = 75% to 95% agreement; majority consent = 50% to 75% agreement; no consensus = less than 50% agreement. RESULTS: There was strong consensus that good skin quality is defined as healthy, youthful in appearance (appearing younger than a person's chronological age), undamaged skin and that skin quality can be described across all ethnicities by four emergent perceptual categories (EPCs): skin tone evenness, skin surface evenness, skin firmness, and skin glow. The EPCs can be affected by multiple tissue layers (ie, skin surface quality can stem from and be impacted by deep structures or tissues). This means that topical approaches may not be sufficient. Instead, improving skin quality EPCs can require a multilayer treatment strategy. CONCLUSION: This global advisory board established strong consensus that skin quality can be described by four EPCs, which can help clinicians determine the appropriate treatment option(s) and the tissue or skin layer(s) to address. Skin quality is important to human health and wellbeing and patients' perception for the need for aesthetic treatment.

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