Pub Date : 2026-12-01Epub Date: 2026-01-06DOI: 10.1080/09546634.2025.2603121
Maria Concetta Fargnoli, Sonja Molin, Anthony Bewley, Christian Apfelbacher, Lysel Brignoli, Alexanne Morillo, Eydna Didriksen Apol, Douglas Maslin, Marie-Noëlle Crépy, Ana Maria Giménez-Arnau
Objectives: Effective management of moderate to severe Chronic Hand Eczema (CHE) requires improved understanding of its etiological subtypes, signs and symptoms, and comorbidities. The objective of this study was to investigate the clinical characteristics of patients with moderate to severe CHE.
Methods: This was a multinational retrospective online chart review in Canada, France, Germany, Italy, Spain, and the UK. Physicians were asked to identify eligible patients from medical records to provide retrospective data over the past 12 months for up to 10 adult patients treated with topical corticosteroids (TCS) or for whom TCS were contraindicated.
Results: A total of 292 physicians completed forms for 1939 patients (56.8% with moderate and 43.2% with severe CHE). The most frequent etiological subtypes were irritant contact dermatitis (40.1%), atopic dermatitis (33.1%) and allergic contact dermatitis (27.5%). Palms (56.6%), fingertips (41.6%) and backs of hands (40.8%) were the most affected areas. Erythema and pruritus were the most frequent signs and symptoms. A history of atopic dermatitis was reported for 43.8% of patients.
Conclusions: In conclusion, patients with moderate to severe CHE present with multiple etiological subtypes and a range of signs and symptoms. Many patients had no atopic condition besides CHE, and no history of atopic dermatitis, indicating that CHE is not simply atopic dermatitis of the hands.
{"title":"Moderate to severe Chronic Hand Eczema in clinical practice: etiological subtypes, clinical signs and symptoms, and comorbidities-results from the RWEAL study.","authors":"Maria Concetta Fargnoli, Sonja Molin, Anthony Bewley, Christian Apfelbacher, Lysel Brignoli, Alexanne Morillo, Eydna Didriksen Apol, Douglas Maslin, Marie-Noëlle Crépy, Ana Maria Giménez-Arnau","doi":"10.1080/09546634.2025.2603121","DOIUrl":"10.1080/09546634.2025.2603121","url":null,"abstract":"<p><strong>Objectives: </strong>Effective management of moderate to severe Chronic Hand Eczema (CHE) requires improved understanding of its etiological subtypes, signs and symptoms, and comorbidities. The objective of this study was to investigate the clinical characteristics of patients with moderate to severe CHE.</p><p><strong>Methods: </strong>This was a multinational retrospective online chart review in Canada, France, Germany, Italy, Spain, and the UK. Physicians were asked to identify eligible patients from medical records to provide retrospective data over the past 12 months for up to 10 adult patients treated with topical corticosteroids (TCS) or for whom TCS were contraindicated.</p><p><strong>Results: </strong>A total of 292 physicians completed forms for 1939 patients (56.8% with moderate and 43.2% with severe CHE). The most frequent etiological subtypes were irritant contact dermatitis (40.1%), atopic dermatitis (33.1%) and allergic contact dermatitis (27.5%). Palms (56.6%), fingertips (41.6%) and backs of hands (40.8%) were the most affected areas. Erythema and pruritus were the most frequent signs and symptoms. A history of atopic dermatitis was reported for 43.8% of patients.</p><p><strong>Conclusions: </strong>In conclusion, patients with moderate to severe CHE present with multiple etiological subtypes and a range of signs and symptoms. Many patients had no atopic condition besides CHE, and no history of atopic dermatitis, indicating that CHE is not simply atopic dermatitis of the hands.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2603121"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145914381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-01-22DOI: 10.1080/09546634.2026.2617770
Diego Orsini, Luca Potestio, Matteo Megna, Chiara Assorgi, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paulo Ferreira, Ana Ferreirinha, Francesca Maria Gaiani, Dario Graceffa, Luciano Ibba, Ana Luísa João, Barbara Leal, Luiz Leite, Maria João Paiva Lopes, Martim Luz, Piergiorgio Malagoli, Pedro Mendes-Bastos, Francesco Messina, Alessandra Narcisi, Giovanni Pellacani, Rita Pimenta, Ângela Roda, Nello Tommasino, Joana Valério, Tiago Torres
Background/objectives: The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-world study aimed to assess the prevalence, predictors, and long-term maintenance of SR status among patients with moderate-to-severe plaque psoriasis treated with risankizumab.
Methods: A retrospective observational study was conducted across 10 Italian and Portuguese referral centers. SRs were defined as patients achieving complete skin clearance (PASI 0) at week 20. Predictors of SR achievement and maintenance were assessed using multivariate logistic regression models at weeks 52, 104, and 130 (2.5 years).
Results: A total of 1372 patients were included (mean PASI 14.9 ± 8.2). At week 20, 610 (44.5%) achieved PASI 0 and were classified as SRs; 84.4% maintained this status at week 52 and 64.9% at 2.5 years. Biologic-naïve status (OR 1.65; p < 0.001) predicted SR achievement, whereas palmoplantar psoriasis (OR 0.58; p = 0.005) and higher BMI (OR 0.96; p = 0.011) negatively influenced it. Biologic-naïve status remained the strongest predictor of long-term maintenance (OR 2.87; p = 0.003).
Conclusions: Risankizumab demonstrated high and sustained long-term effectiveness, inducing rapid and sustained complete clearance in a substantial proportion of patients.
背景/目的:超级应答者(SRs)的概念在银屑病治疗中越来越受到关注。然而,仅针对利桑单抗的证据仍然有限。这项多中心、国际、真实世界的研究旨在评估接受利桑单抗治疗的中重度斑块型银屑病患者的患病率、预测因素和SR状态的长期维持。方法:对10个意大利和葡萄牙转诊中心进行回顾性观察性研究。SRs定义为患者在第20周达到完全皮肤清除率(PASI 0)。在第52周、104周和130周(2.5年)使用多变量logistic回归模型评估SR实现和维持的预测因子。结果:共纳入1372例患者(平均PASI 14.9±8.2)。在第20周,610例(44.5%)达到PASI 0,并被归类为sr;84.4%的患者在52周和64.9%的患者在2年半时仍保持这种状态。Biologic-naïve状态(OR 1.65; p = 0.005)和较高的BMI (OR 0.96; p = 0.011)对其有负向影响。Biologic-naïve状态仍然是长期维持的最强预测因子(OR 2.87; p = 0.003)。结论:Risankizumab显示出高且持续的长期有效性,在相当比例的患者中诱导快速且持续的完全清除。
{"title":"Risankizumab super responders in moderate-to-severe psoriasis: prevalence, predictors, and long-term maintenance in a multicenter, international, real-world cohort.","authors":"Diego Orsini, Luca Potestio, Matteo Megna, Chiara Assorgi, Antonio Costanzo, Annunziata Dattola, Maria Concetta Fargnoli, Paulo Ferreira, Ana Ferreirinha, Francesca Maria Gaiani, Dario Graceffa, Luciano Ibba, Ana Luísa João, Barbara Leal, Luiz Leite, Maria João Paiva Lopes, Martim Luz, Piergiorgio Malagoli, Pedro Mendes-Bastos, Francesco Messina, Alessandra Narcisi, Giovanni Pellacani, Rita Pimenta, Ângela Roda, Nello Tommasino, Joana Valério, Tiago Torres","doi":"10.1080/09546634.2026.2617770","DOIUrl":"10.1080/09546634.2026.2617770","url":null,"abstract":"<p><strong>Background/objectives: </strong>The concept of super responders (SRs) has gained increasing attention in psoriasis. However, evidence focusing exclusively on risankizumab remains limited. This multicenter, international, real-world study aimed to assess the prevalence, predictors, and long-term maintenance of SR status among patients with moderate-to-severe plaque psoriasis treated with risankizumab.</p><p><strong>Methods: </strong>A retrospective observational study was conducted across 10 Italian and Portuguese referral centers. SRs were defined as patients achieving complete skin clearance (PASI 0) at week 20. Predictors of SR achievement and maintenance were assessed using multivariate logistic regression models at weeks 52, 104, and 130 (2.5 years).</p><p><strong>Results: </strong>A total of 1372 patients were included (mean PASI 14.9 ± 8.2). At week 20, 610 (44.5%) achieved PASI 0 and were classified as SRs; 84.4% maintained this status at week 52 and 64.9% at 2.5 years. Biologic-naïve status (OR 1.65; <i>p</i> < 0.001) predicted SR achievement, whereas palmoplantar psoriasis (OR 0.58; <i>p</i> = 0.005) and higher BMI (OR 0.96; <i>p</i> = 0.011) negatively influenced it. Biologic-naïve status remained the strongest predictor of long-term maintenance (OR 2.87; <i>p</i> = 0.003).</p><p><strong>Conclusions: </strong>Risankizumab demonstrated high and sustained long-term effectiveness, inducing rapid and sustained complete clearance in a substantial proportion of patients.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2617770"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146032208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Reconstruction of full-thickness lower-lip defects after skin cancer excision is challenging, as both oral function and appearance must be restored. Conventional methods may be insufficient for moderate-sized defects.
Materials and methods: This prospective observational study included 36 patients with T1-T2N0M0 basal or squamous cell carcinoma (SCC) of the lower lip treated between January 2021 and April 2023. Defects involving roughly one-third to two-thirds of the lip were repaired using a combined subcutaneous pedicle flap and labial mucosa flap. Patients were followed for 6-24 months. Functional and aesthetic outcomes, wound healing, scar quality, and recurrence were assessed using standardized scoring systems.
Results: Delayed healing was more common in patients over 70 years (37.5% vs. 5.0%). Defects > 2.0 cm had lower functional scores and higher delayed healing. Moist wound care reduced delayed healing compared with dry healing (exploratory). Tumor recurrence was 10.5% for SCC and 5.8% for BCC. Overall, functional and aesthetic outcomes remained high.
Conclusions: The combined flap technique is a safe, effective option for moderate-sized full-thickness lower-lip defects, providing reliable functional restoration and satisfactory cosmetic results.
{"title":"Application of a subcutaneous tissue pedicle flap combined with a labial mucosa flap for reconstruction of full-thickness lower lip defects: a prospective observational study.","authors":"Jianbo Chen, Zhibing Fu, Yifei Xie, Ningling Wu, Lu Zhou, Yujin Li, Meng Wu, Zeng Jinrong","doi":"10.1080/09546634.2026.2617778","DOIUrl":"https://doi.org/10.1080/09546634.2026.2617778","url":null,"abstract":"<p><strong>Background: </strong>Reconstruction of full-thickness lower-lip defects after skin cancer excision is challenging, as both oral function and appearance must be restored. Conventional methods may be insufficient for moderate-sized defects.</p><p><strong>Materials and methods: </strong>This prospective observational study included 36 patients with T1-T2N0M0 basal or squamous cell carcinoma (SCC) of the lower lip treated between January 2021 and April 2023. Defects involving roughly one-third to two-thirds of the lip were repaired using a combined subcutaneous pedicle flap and labial mucosa flap. Patients were followed for 6-24 months. Functional and aesthetic outcomes, wound healing, scar quality, and recurrence were assessed using standardized scoring systems.</p><p><strong>Results: </strong>Delayed healing was more common in patients over 70 years (37.5% <i>vs</i>. 5.0%). Defects > 2.0 cm had lower functional scores and higher delayed healing. Moist wound care reduced delayed healing compared with dry healing (exploratory). Tumor recurrence was 10.5% for SCC and 5.8% for BCC. Overall, functional and aesthetic outcomes remained high.</p><p><strong>Conclusions: </strong>The combined flap technique is a safe, effective option for moderate-sized full-thickness lower-lip defects, providing reliable functional restoration and satisfactory cosmetic results.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2617778"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146145356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-02-05DOI: 10.1080/09546634.2026.2627102
Luigi Gargiulo, Matteo Bianco, Luciano Ibba, Sara Di Giulio, Antonio Costanzo, Alessandra Narcisi
{"title":"Dose escalation and personalization in atopic dermatitis: reply to the real-world study by Demirbaş et al. \"<i>Dose-dependent effectiveness and patient-reported outcomes with JAK1 inhibitors in atopic dermatitis: a 36-week multicenter real-world cohort.</i>\".","authors":"Luigi Gargiulo, Matteo Bianco, Luciano Ibba, Sara Di Giulio, Antonio Costanzo, Alessandra Narcisi","doi":"10.1080/09546634.2026.2627102","DOIUrl":"https://doi.org/10.1080/09546634.2026.2627102","url":null,"abstract":"","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2627102"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146128158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-02-03DOI: 10.1080/09546634.2026.2624225
Yoshihito Mima, Masako Yamamoto, Ken Iozumi
Backgrounds: Prurigo nodularis (PN) is a chronic pruritic inflammatory disease associated with immune and neural dysregulation. Although nemolizumab has demonstrated efficacy in clinical trials, real-world post-marketing data remain limited.
Objective: To evaluate the real-world efficacy, safety, and drug survival of nemolizumab in patients with PN.
Materials and methods: We retrospectively analyzed 38 patients with PN treated with nemolizumab at a single center. Peak Pruritus Numerical Rating Scale (PP-NRS) and Prurigo Nodularis Investigator's Global Assessment (PN-IGA) were assessed up to Week 24. Treatment-emergent adverse events (TEAEs) and drug survival were evaluated.
Results: Mean PP-NRS rapidly improved from 8.1 at baseline to 1.8 at Week 8 and remained stable through Week 24 (p < 0.001). PN-IGA scores gradually improved from 3.1 to 1.4 by Week 24 (p < 0.01). At Week 24, ≥4-point PP-NRS improvement and PP-NRS 0/1 were achieved in 90.9% and 59.1% of patients, respectively, while PN-IGA 0/1 was achieved in 50.0%. Early PP-NRS improvement correlated with long-term outcomes. TEAEs occurred in 39.5%, mainly cutaneous reactions, and drug survival was significantly lower in patients with TEAEs.
Conclusion: Nemolizumab provided rapid and sustained itch relief with gradual lesion improvement in real-world PN. Early pruritus response may predict long-term efficacy, while adverse events affect treatment persistence.
{"title":"24-week real world outcomes of nemolizumab in patients with prurigo nodularis.","authors":"Yoshihito Mima, Masako Yamamoto, Ken Iozumi","doi":"10.1080/09546634.2026.2624225","DOIUrl":"https://doi.org/10.1080/09546634.2026.2624225","url":null,"abstract":"<p><strong>Backgrounds: </strong>Prurigo nodularis (PN) is a chronic pruritic inflammatory disease associated with immune and neural dysregulation. Although nemolizumab has demonstrated efficacy in clinical trials, real-world post-marketing data remain limited.</p><p><strong>Objective: </strong>To evaluate the real-world efficacy, safety, and drug survival of nemolizumab in patients with PN.</p><p><strong>Materials and methods: </strong>We retrospectively analyzed 38 patients with PN treated with nemolizumab at a single center. Peak Pruritus Numerical Rating Scale (PP-NRS) and Prurigo Nodularis Investigator's Global Assessment (PN-IGA) were assessed up to Week 24. Treatment-emergent adverse events (TEAEs) and drug survival were evaluated.</p><p><strong>Results: </strong>Mean PP-NRS rapidly improved from 8.1 at baseline to 1.8 at Week 8 and remained stable through Week 24 (<i>p</i> < 0.001). PN-IGA scores gradually improved from 3.1 to 1.4 by Week 24 (<i>p</i> < 0.01). At Week 24, ≥4-point PP-NRS improvement and PP-NRS 0/1 were achieved in 90.9% and 59.1% of patients, respectively, while PN-IGA 0/1 was achieved in 50.0%. Early PP-NRS improvement correlated with long-term outcomes. TEAEs occurred in 39.5%, mainly cutaneous reactions, and drug survival was significantly lower in patients with TEAEs.</p><p><strong>Conclusion: </strong>Nemolizumab provided rapid and sustained itch relief with gradual lesion improvement in real-world PN. Early pruritus response may predict long-term efficacy, while adverse events affect treatment persistence.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2624225"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146115535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-02-05DOI: 10.1080/09546634.2026.2617768
Julia Sternicka-Rohde, Leszek Bieniaszewski, Roman J Nowicki, Dorota Purzycka-Bohdan
Objectives: Off-label prescribing is a common and often necessary practice in dermatology, as approved treatment options frequently fail to meet the diverse needs of patients. This is particularly relevant in the management of two prevalent inflammatory dermatoses - atopic dermatitis and psoriasis. Despite the widespread use of off-label therapies, their application often lacks formal guidance, highlighting the need for updated clinical recommendations and consideration of expanded drug indications.
Methods: This retrospective study analyzed medical records of 5072 patients with atopic dermatitis and/or psoriasis who were treated in Northern Poland between 2014 and 2024.
Results: It was found that 62.5% of patients with atopic dermatitis and 25.7% of patients with psoriasis received some form of off-label treatment. The frequency of off-label therapy demonstrated an inverse correlation with patient age. On average, individuals managed with a combination of on-label and off-label therapies achieved greater reductions in EASI, PASI, and DLQI scores compared to those treated exclusively according to SmPC guidelines, with the statistically significant difference for PASI reductions.
Conclusions: Off-label treatment is widely used in the management of both atopic dermatitis and psoriasis. Real-world evidence plays a crucial role in guiding clinical practice and should be leveraged to support the more evidence-based implementation of off-label therapies.
{"title":"Off-label treatment of atopic dermatitis and psoriasis.","authors":"Julia Sternicka-Rohde, Leszek Bieniaszewski, Roman J Nowicki, Dorota Purzycka-Bohdan","doi":"10.1080/09546634.2026.2617768","DOIUrl":"https://doi.org/10.1080/09546634.2026.2617768","url":null,"abstract":"<p><strong>Objectives: </strong>Off-label prescribing is a common and often necessary practice in dermatology, as approved treatment options frequently fail to meet the diverse needs of patients. This is particularly relevant in the management of two prevalent inflammatory dermatoses - atopic dermatitis and psoriasis. Despite the widespread use of off-label therapies, their application often lacks formal guidance, highlighting the need for updated clinical recommendations and consideration of expanded drug indications.</p><p><strong>Methods: </strong>This retrospective study analyzed medical records of 5072 patients with atopic dermatitis and/or psoriasis who were treated in Northern Poland between 2014 and 2024.</p><p><strong>Results: </strong>It was found that 62.5% of patients with atopic dermatitis and 25.7% of patients with psoriasis received some form of off-label treatment. The frequency of off-label therapy demonstrated an inverse correlation with patient age. On average, individuals managed with a combination of on-label and off-label therapies achieved greater reductions in EASI, PASI, and DLQI scores compared to those treated exclusively according to SmPC guidelines, with the statistically significant difference for PASI reductions.</p><p><strong>Conclusions: </strong>Off-label treatment is widely used in the management of both atopic dermatitis and psoriasis. Real-world evidence plays a crucial role in guiding clinical practice and should be leveraged to support the more evidence-based implementation of off-label therapies.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2617768"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146128136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objectives: Compared with placebo, this phase I study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free minoxidil-finasteride combination topical foam, in Chinese males with androgenetic alopecia (AGA).
Methods: In this randomized, double-blind, placebo-controlled trial, 44 subjects received single and multiple doses across five cohorts with varying finasteride concentrations (0.025%-0.1%) and frequencies. Safety, tolerability, and pharmacokinetics were evaluated. The concentrations of minoxidil-finasteride were both measured.
Results: The result shows that CG2001 was safe and well-tolerated, with no serious adverse events. Systemic minoxidil exposure was consistent across most dosages, while finasteride exposure increased dose- and frequency-dependently, though it remained markedly lower than that reported with oral administration. Steady state was achieved for both drugs after 7 days.
Conculsions: The favorable safety profile and reduced systemic finasteride exposure position CG2001 as a promising alternative, supporting further clinical development in a phase IIa trial, and provide a pharmacokinetic foundation for subsequent efficacy trials in patients with AGA.
{"title":"Safety, tolerability, and pharmacokinetics of CG2001 in Chinese adult male subjects with androgenetic alopecia: a randomized, double-blind, placebo-controlled, single- and multi-doses, phase 1 clinical study.","authors":"Yanting Li, Baohui Yu, Suping Niu, Ziyan Ding, Qun Gu, Hui Zhang, Rui Ding, Cheng Zhou, Fang Men, Yian Liu, Wenyan Zhao, Liming Chen, Shuang Li, Qian Wang, Meng Xiao, Fan Huang, Binyi Hu, Jiaojiao Zhang, Jianzhong Zhang, Yi Fang","doi":"10.1080/09546634.2026.2616198","DOIUrl":"https://doi.org/10.1080/09546634.2026.2616198","url":null,"abstract":"<p><strong>Objectives: </strong>Compared with placebo, this phase I study evaluated the safety, tolerability, and pharmacokinetics of CG2001, a novel isopropyl alcohol-free minoxidil-finasteride combination topical foam, in Chinese males with androgenetic alopecia (AGA).</p><p><strong>Methods: </strong>In this randomized, double-blind, placebo-controlled trial, 44 subjects received single and multiple doses across five cohorts with varying finasteride concentrations (0.025%-0.1%) and frequencies. Safety, tolerability, and pharmacokinetics were evaluated. The concentrations of minoxidil-finasteride were both measured.</p><p><strong>Results: </strong>The result shows that CG2001 was safe and well-tolerated, with no serious adverse events. Systemic minoxidil exposure was consistent across most dosages, while finasteride exposure increased dose- and frequency-dependently, though it remained markedly lower than that reported with oral administration. Steady state was achieved for both drugs after 7 days.</p><p><strong>Conculsions: </strong>The favorable safety profile and reduced systemic finasteride exposure position CG2001 as a promising alternative, supporting further clinical development in a phase IIa trial, and provide a pharmacokinetic foundation for subsequent efficacy trials in patients with AGA.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2616198"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146101264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-02-02DOI: 10.1080/09546634.2026.2622858
Mohammed Shanshal
{"title":"Prurigo nodularis enters the biologic era: what has changed and what vixarelimab still must prove.","authors":"Mohammed Shanshal","doi":"10.1080/09546634.2026.2622858","DOIUrl":"https://doi.org/10.1080/09546634.2026.2622858","url":null,"abstract":"","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2622858"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-12-01Epub Date: 2026-02-02DOI: 10.1080/09546634.2026.2622245
Nader A Al-Aizari, Hashem M Al-Shamiri, Bayan K AlShehri, Khalid S Alhomood, Saeed R Alzahrani, Waad R Abuhasna, Sadeq Ali Al-Maweri
Objective: To compare the effectiveness and safety of pharmacological, physical, and complementary interventions for recurrent aphthous stomatitis (RAS) across clinically relevant outcomes.
Methods: This umbrella review was conducted according to PRISMA and Cochrane guidance and registered in PROSPERO (CRD42024594292). PubMed, Scopus, and the Cochrane Library were searched through August 2025. Eligible studies were systematic reviews, meta-analyses, or network meta-analyses evaluating treatments for RAS. Methodological quality was assessed using AMSTAR 2, and overlap of primary studies was quantified using the corrected covered area.
Results: A total of 41 reviews were included. Topical corticosteroids and low-level laser therapy consistently reduced pain and shortened healing time, although evidence for recurrence prevention was limited. Hyaluronic acid and herbal agents demonstrated favorable short-term efficacy with good safety profiles. Systemic agents such as colchicine and thalidomide showed benefit in severe or refractory RAS, but were constrained by the adverse effects and low-certainty evidence.
Conclusion: Evidence supports topical corticosteroids, hyaluronic acid, and laser therapy for short-term symptom control in RAS, while systemic agents should be reserved for selected refractory cases.
{"title":"Evidence-based recommendations for the treatment of recurrent aphthous stomatitis: insights from an umbrella review.","authors":"Nader A Al-Aizari, Hashem M Al-Shamiri, Bayan K AlShehri, Khalid S Alhomood, Saeed R Alzahrani, Waad R Abuhasna, Sadeq Ali Al-Maweri","doi":"10.1080/09546634.2026.2622245","DOIUrl":"https://doi.org/10.1080/09546634.2026.2622245","url":null,"abstract":"<p><strong>Objective: </strong>To compare the effectiveness and safety of pharmacological, physical, and complementary interventions for recurrent aphthous stomatitis (RAS) across clinically relevant outcomes.</p><p><strong>Methods: </strong>This umbrella review was conducted according to PRISMA and Cochrane guidance and registered in PROSPERO (CRD42024594292). PubMed, Scopus, and the Cochrane Library were searched through August 2025. Eligible studies were systematic reviews, meta-analyses, or network meta-analyses evaluating treatments for RAS. Methodological quality was assessed using AMSTAR 2, and overlap of primary studies was quantified using the corrected covered area.</p><p><strong>Results: </strong>A total of 41 reviews were included. Topical corticosteroids and low-level laser therapy consistently reduced pain and shortened healing time, although evidence for recurrence prevention was limited. Hyaluronic acid and herbal agents demonstrated favorable short-term efficacy with good safety profiles. Systemic agents such as colchicine and thalidomide showed benefit in severe or refractory RAS, but were constrained by the adverse effects and low-certainty evidence.</p><p><strong>Conclusion: </strong>Evidence supports topical corticosteroids, hyaluronic acid, and laser therapy for short-term symptom control in RAS, while systemic agents should be reserved for selected refractory cases.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2622245"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Rosacea is a common chronic inflammatory skin disease. Mast cells are implicated in the pathogenesis of rosacea. However, the therapeutic potential of tranilast, a mast cell membrane stabilizer, remains unexplored. This study aims to evaluate the efficacy and safety of tranilast monotherapy and in combination with minocycline in patients with moderate-to-severe rosacea.
Methods: This study has been registered on ClinicalTrials.gov (Registration No. NCT06307223). All enrolled patients with rosacea were randomly assigned to receive tranilast, minocycline, or a combination of both. Tranilast (0.1 g, three times daily) and minocycline (50 mg, once daily) were administered for 12 weeks, with follow-up every two weeks.
Results: Forty-five patients completed the study. At week 12, the combination group showed a significantly higher IGA success rate (93.33%) compared to the tranilast (53.33%) and minocycline (46.67%) groups (p < 0.05). The secondary endpoints, such as CEA success rate, erythema index, and erythema score, also favored the combination group over minocycline group (p = 0.021, 0.030, and 0.024, respectively).
Conclusion: In our study, patients with moderate to severe rosacea treated with tranilast showed a favorable clinical response and experienced no serious adverse events. The combination therapy yielded better outcomes than minocycline monotherapy, especially in improving facial erythema.
{"title":"Efficacy and safety of tranilast combined with minocycline in the treatment of moderate-to-severe rosacea: a prospective, randomized controlled study.","authors":"Jingchen Liang, Ying Chen, Mengyao Yang, Hongshan Liu, Yale Liu, Shujuan He, Zhao Wang, Weihui Zeng","doi":"10.1080/09546634.2025.2597711","DOIUrl":"10.1080/09546634.2025.2597711","url":null,"abstract":"<p><strong>Background: </strong>Rosacea is a common chronic inflammatory skin disease. Mast cells are implicated in the pathogenesis of rosacea. However, the therapeutic potential of tranilast, a mast cell membrane stabilizer, remains unexplored. This study aims to evaluate the efficacy and safety of tranilast monotherapy and in combination with minocycline in patients with moderate-to-severe rosacea.</p><p><strong>Methods: </strong>This study has been registered on ClinicalTrials.gov (Registration No. NCT06307223). All enrolled patients with rosacea were randomly assigned to receive tranilast, minocycline, or a combination of both. Tranilast (0.1 g, three times daily) and minocycline (50 mg, once daily) were administered for 12 weeks, with follow-up every two weeks.</p><p><strong>Results: </strong>Forty-five patients completed the study. At week 12, the combination group showed a significantly higher IGA success rate (93.33%) compared to the tranilast (53.33%) and minocycline (46.67%) groups (<i>p</i> < 0.05). The secondary endpoints, such as CEA success rate, erythema index, and erythema score, also favored the combination group over minocycline group (<i>p</i> = 0.021, 0.030, and 0.024, respectively).</p><p><strong>Conclusion: </strong>In our study, patients with moderate to severe rosacea treated with tranilast showed a favorable clinical response and experienced no serious adverse events. The combination therapy yielded better outcomes than minocycline monotherapy, especially in improving facial erythema.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"37 1","pages":"2597711"},"PeriodicalIF":3.9,"publicationDate":"2026-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145807186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}