Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-18DOI: 10.1007/s13555-025-01490-3
Jennifer Soung, Vivian Laquer, Matthew Zirwas, Peter van Iperen, John C Stinson, Katrine Lykke Albertsen, Linda Stein Gold
{"title":"The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA).","authors":"Jennifer Soung, Vivian Laquer, Matthew Zirwas, Peter van Iperen, John C Stinson, Katrine Lykke Albertsen, Linda Stein Gold","doi":"10.1007/s13555-025-01490-3","DOIUrl":"10.1007/s13555-025-01490-3","url":null,"abstract":"<p><strong>Introduction: </strong>The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300 mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.</p><p><strong>Methods: </strong>This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12 years with Investigator's Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300 mg via self-administered pre-filled pen every 2 weeks for 16 weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week 16. Safety was assessed as the number of adverse events from baseline to week 16.</p><p><strong>Results: </strong>At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.</p><p><strong>Conclusions: </strong>Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05194540.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2631-2644"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy and Safety of Cold Atmospheric Plasma-Assisted Therapy for Herpes Zoster: A Randomized, Parallel, Positive-Controlled, Non-inferiority Multicenter Clinical Trial.","authors":"Jingwen Wang, Ke Xue, Jing Gao, Chengda Yuan, Zebin Meng, Linge Li, Lili He, Chenchen Zhang, Xingyu Yang, Jing Wang, Yongmei Lv, Xin Du, Liyun Wang, Chuyu Fu, Na Wang, Yuyan Cheng, Feng Wang, Qing Li, Tingfang Zhang, Yong Cui, Chunjun Yang","doi":"10.1007/s13555-025-01467-2","DOIUrl":"10.1007/s13555-025-01467-2","url":null,"abstract":"<p><strong>Introduction: </strong>There is growing evidence that cold atmospheric plasma (CAP) can boost skin wound healing and inhibit various viruses. Here, we evaluated the effectiveness and safety of CAP as an adjunct treatment for herpes zoster (HZ). We hypothesized that CAP was similar to or better than the helium-neon (He-Ne) laser in promoting HZ wound and pain recovery.</p><p><strong>Methods: </strong>We recruited 187 patients with acute HZ who received either CAP once per day for at least 2 min per treatment area or He-Ne laser therapy once per day for 20 min per session, in addition to a standard treatment regime. The primary endpoint was the efficacy rate, defined as the percentage of patients in each group whose treated area exhibited drying of blisters in ≥ 50% of the area after the final treatment. Secondary evaluation indicators included treatment duration (in days), onset time of scabbing, scab rate, visual analog scale pain scores, and quality of life scores.</p><p><strong>Results: </strong>Efficacy rates after the last treatment were not significantly different between the CAP and He-Ne laser groups (at 3 ± 1 and 10 ± 2 days after the last treatment, respectively, p > 0.05). Treatment duration, scab formation onset time, and complete scab formation time were shorter in the CAP group than in the He-Ne laser group. No severe adverse events or reactions occurred in the CAP group.</p><p><strong>Conclusion: </strong>CAP is an effective and safe therapeutic option for HZ.</p><p><strong>Trial registration: </strong>This study has been registered at www.chictr.org.cn (ChiCTR2300069993). A graphical abstract is available for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2391-2408"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354407/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539487","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-02DOI: 10.1007/s13555-025-01474-3
Bruce Strober, Manish Patel, Mark I Kaldas, Greg St John, Huzefa Photowala, Adam P Sima, Thomas Eckmann, Alicia Beeghly, April Armstrong
{"title":"Real-World Skin Clearance and Quality of Life with risankizumab in Patients with Psoriasis with Moderate Skin Involvement and Those Eligible for Systemic Therapy Per International Psoriasis Council Classification.","authors":"Bruce Strober, Manish Patel, Mark I Kaldas, Greg St John, Huzefa Photowala, Adam P Sima, Thomas Eckmann, Alicia Beeghly, April Armstrong","doi":"10.1007/s13555-025-01474-3","DOIUrl":"10.1007/s13555-025-01474-3","url":null,"abstract":"<p><strong>Introduction: </strong>The International Psoriasis Council (IPC) reclassified patients eligible for systemic therapy to include those with body surface area (BSA) > 10%, psoriasis lesions in high-impact areas, or failure of topical therapy. Risankizumab is an interleukin-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis. This retrospective study evaluated the real-world effectiveness of risankizumab in patients with BSA 3-10% and patients meeting IPC systemic therapy criteria, addressing existing gaps in knowledge regarding its effectiveness in these patient groups.</p><p><strong>Methods: </strong>Biologic-naïve adults with moderate-to-severe plaque psoriasis who initiated risankizumab between April 2019 and August 2023 and were treated for 12 (± 3) months were identified from the CorEvitas Psoriasis Registry and stratified by baseline BSA. At 12 months, skin clearance was assessed by achievement of Psoriasis Area Severity Index (PASI) 90, PASI 100, and National Psoriasis Foundation (NPF) treat-to-target goals. Patient-reported outcomes (PROs) included achievement of Dermatology Life Quality Index (DLQI) 0/1, improvements in psoriasis symptoms, and work and activity impairment.</p><p><strong>Results: </strong>Of 272 patients analyzed, 123 had BSA 3-10% (78 had any high-impact area involvement and 105 had prior topical therapy experience) and 149 patients had BSA > 10%. Among those with BSA 3-10%, 77.9% achieved PASI 90 and 67.2% achieved PASI 100. NPF acceptable and target responses were met by 95.3% and 87.9%, respectively. Regarding PROs, 68.1% of patients with moderate skin involvement (BSA 3-10%) attained a DLQI score of 0/1. Significant improvements from baseline in psoriasis symptoms and reductions in work and life impairments were also reported (P < .001). Comparable positive outcomes were observed across all IPC systemic therapy eligible patient subgroups.</p><p><strong>Conclusion: </strong>In patients with BSA 3-10% and those systemic-eligible per IPC classification, continuous treatment with risankizumab for 12 months resulted in high levels of skin clearance and improvements in PROs.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2409-2421"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354662/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-18DOI: 10.1007/s13555-025-01499-8
Esteban Daudén, Isabel Belinchón, Elena Colominas-González, Pablo Coto, Pablo de la Cueva, Fernando Gallardo, Jose Luis Poveda, Esther Ramírez, Sandra Ros, Ricardo Ruíz-Villaverde, Isabel Cabezas, Luis Lizán
{"title":"Well-Being in Psoriasis: Weighting its Components Using Best-worst Scaling Methodology.","authors":"Esteban Daudén, Isabel Belinchón, Elena Colominas-González, Pablo Coto, Pablo de la Cueva, Fernando Gallardo, Jose Luis Poveda, Esther Ramírez, Sandra Ros, Ricardo Ruíz-Villaverde, Isabel Cabezas, Luis Lizán","doi":"10.1007/s13555-025-01499-8","DOIUrl":"10.1007/s13555-025-01499-8","url":null,"abstract":"<p><strong>Introduction: </strong>The Inpsight Project, established in 2021, aimed to define the concept of well-being in patients with psoriasis from a holistic perspective. Well-being was defined as a multi-dimensional concept that includes achieving emotional balance, having adequate overall health and control of the disease, enjoying positive social relationships, and being satisfied with disease care. However, while these components are recognized as integral to the concept, their relative contribution to achieving optimal well-being remains unclear. To address this gap, the present study aimed to determine the relative weight of each component in contributing to optimal well-being, focusing on a Spanish population.</p><p><strong>Methods: </strong>An observational, descriptive, cross-sectional study was conducted in Spain using best-worst scaling (BWS). Two questionnaires were developed: one addressed to patients (33 item) and the other to healthcare professionals (HCPs) (18 item). The questionnaires collected sociodemographic and clinical (patients)/occupational (HCP) characteristics of the participants and the BWS scenarios. The 20 components of well-being were randomly distributed across 76 scenarios, with each component paired with others four times to ensure a comprehensive evaluation of all possible combinations. Participants assessed 9-10 randomly selected scenarios and identified the components they considered most (best) and least (worst) important for achieving optimal well-being.</p><p><strong>Results: </strong>A total of 87 HCPs and 152 patients with psoriasis participated in the study. The five key components for patients were pain (P: 100.00), stress (P: 98.74), treatment satisfaction (92.21), itching (72.05), and lesions in functional locations (P: 69.09). From a HCP perspective, the most important components were mood disorders (100.00), pain (69.39), lesions in functional locations (49.34), self-esteem (49.24), and stigmatization/shame (45.22).</p><p><strong>Conclusions: </strong>This study highlights the differences between patients and HCPs in their perception of the relative importance and relevance of the components contributing to the well-being of patients with psoriasis. Future research should focus on understanding the cumulative impact of psoriasis on patient well-being.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2645-2656"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144658670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-22DOI: 10.1007/s13555-025-01489-w
Andrew F Alexis, Leon Kircik, Raj Chovatiya, Zakiya P Rice, Weily Soong, Tina Bhutani, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman, April W Armstrong
{"title":"Tapinarof Cream for Adults and Children with Atopic Dermatitis-Efficacy by Race and Fitzpatrick Skin Type in Two Phase 3 Randomized Clinical Trials.","authors":"Andrew F Alexis, Leon Kircik, Raj Chovatiya, Zakiya P Rice, Weily Soong, Tina Bhutani, Philip M Brown, Stephen C Piscitelli, David S Rubenstein, Anna M Tallman, April W Armstrong","doi":"10.1007/s13555-025-01489-w","DOIUrl":"10.1007/s13555-025-01489-w","url":null,"abstract":"<p><strong>Introduction: </strong>Patients with atopic dermatitis (AD) and skin of color have heterogeneous presentations and treatment outcomes, however, they are underrepresented in trials. In the ADORING 1 and 2 phase 3, 8-week randomized trials, tapinarof cream 1% once daily (QD) demonstrated superior efficacy versus vehicle in adults and children down to age 2 years with AD. These analyses evaluate efficacy of tapinarof cream 1% QD stratified by race and Fitzpatrick skin type.</p><p><strong>Methods: </strong>The primary endpoint was a Validated Investigator Global Assessment for Atopic Dermatitis™ (vIGA-AD™) score of 0 (clear) or 1 (almost clear) and ≥ 2-grade improvement from baseline at week 8. Secondary endpoints included achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI75). Efficacy evaluations used race categories of Asian, Black or African American, and white, and Fitzpatrick skin types I-III and IV-VI.</p><p><strong>Results: </strong>In ADORING 1 and 2, 407 and 406 patients were randomized to tapinarof or vehicle QD (7.3-17.0% Asian; 25.9-35.1% Black/African American 43.0-57.7% white), respectively. Across trials, > 50% had Fitzpatrick skin types IV-VI. Tapinarof demonstrated significant efficacy in adults and children. By race in both trials, the primary endpoint was met by consistently higher proportions treated with tapinarof than vehicle: Asian, 39.5-48.9% versus 3.7-18.5%; Black/African American, 43.1-47.0% versus 17.5-24.1%; white, 49.4-52.1% versus 12.2-14.5%, respectively. Similar, superior responses were reported across Fitzpatrick skin type groups with tapinarof versus vehicle: I-III, 44.8-49.9% versus 13.5-17.7%; IV-VI, 46.8-49.6% versus 15.3-19.5%. EASI75 responses were similarly higher and consistent with tapinarof versus vehicle. Adverse events were mostly mild or moderate, leading to low trial discontinuations (lower with tapinarof than vehicle).</p><p><strong>Conclusions: </strong>Tapinarof demonstrated consistent efficacy and was well tolerated versus vehicle in a large, diverse population with AD, regardless of race or Fitzpatrick skin type.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT05014568, NCT05032859. Graphical Abstract avaliable for this article.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2667-2682"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144689424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-15DOI: 10.1007/s13555-025-01481-4
Emma Guttman-Yassky, Zhe Sun, Laura Rebeca Mena, Nathan Hahn, Brian J Nickoloff, Christoph Preuss, Kimberly Siu, Chitra R Natalie, Gaia Gallo, Eric Wolf, Kilian Eyerich, Mònica Aparici, Robert J Benschop, Angela Okragly
{"title":"Lebrikizumab Rapidly Lowers Inflammatory Biomarkers with Clinical Correlations in Moderate-to-Severe Atopic Dermatitis.","authors":"Emma Guttman-Yassky, Zhe Sun, Laura Rebeca Mena, Nathan Hahn, Brian J Nickoloff, Christoph Preuss, Kimberly Siu, Chitra R Natalie, Gaia Gallo, Eric Wolf, Kilian Eyerich, Mònica Aparici, Robert J Benschop, Angela Okragly","doi":"10.1007/s13555-025-01481-4","DOIUrl":"10.1007/s13555-025-01481-4","url":null,"abstract":"<p><strong>Introduction: </strong>Lebrikizumab is a novel monoclonal antibody that selectively binds to interleukin (IL)-13 with high affinity and a slow dissociation rate.</p><p><strong>Methods: </strong>We assayed serum from select patients enrolled in ADvocate1 and ADvocate2 to determine the impact of lebrikizumab on circulating biomarkers and pathways relevant to atopic dermatitis (AD) and to assess the correlation between key biomarkers and clinical measures of improvement.</p><p><strong>Results: </strong>At baseline, IL-13, CC motif chemokine ligand (CCL)13, CCL17, CCL22, total immunoglobulin (Ig)E, IL-5, and periostin were elevated in patients with moderate-to-severe AD versus healthy controls (p < 0.001). Baseline Eczema and Area Severity Index (EASI) and Investigator's Global Assessment (IGA) scores were significantly correlated with IL-13, IL-5, CCL13, CCL22, and CCL26. Lebrikizumab induced rapid and progressive reductions in CCL13, CCL17, CCL22, and periostin at weeks 4, 16, and 52 compared with baseline (p < 0.05). AD-associated pathways linked to cytokine signaling were significantly improved at weeks 4 and 16. Improvements in EASI, IGA, and the Pruritus Numeric Rating Scale were correlated with reductions in CCL13, CCL17, CCL22, CCL26, and periostin across all time points. After multiple testing correction and adjusting for sex and race as covariates, we identified the chemokine CCL26 as a pharmacodynamic marker for lebrikizumab response at weeks 4 and 16.</p><p><strong>Conclusions: </strong>Selective inhibition of IL-13 with lebrikizumab monotherapy induced progressive inhibition of systemic biomarkers and pathways of type 2 inflammation, which correlated with clinical measures of improvement in patients with moderate-to-severe AD.</p><p><strong>Clinical trial registrations: </strong>NCT04146363 and NCT04178967.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2595-2614"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144636521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-05DOI: 10.1007/s13555-025-01472-5
Ao Shi, Yuan Shu, Joe El Haddad, Shuqin Wu, Karen Smayra, Shivon Mirza Sudesh, Mohammed Majd Mourad, Armin Farzad, Nathanael Yap, Efstathia Andrikopoulou, Qi Liu, Pengyang Li, Ying Tu
{"title":"Cardiovascular and Kidney Outcomes After Systemic Treatment for Plaque Psoriasis: A Systematic Review and Network Meta-analysis.","authors":"Ao Shi, Yuan Shu, Joe El Haddad, Shuqin Wu, Karen Smayra, Shivon Mirza Sudesh, Mohammed Majd Mourad, Armin Farzad, Nathanael Yap, Efstathia Andrikopoulou, Qi Liu, Pengyang Li, Ying Tu","doi":"10.1007/s13555-025-01472-5","DOIUrl":"10.1007/s13555-025-01472-5","url":null,"abstract":"<p><strong>Introduction: </strong>Systemic immunomodulatory treatments may affect cardiovascular and renal outcomes in patients with chronic plaque psoriasis. We conducted a network meta-analysis (NMA) to compare these outcomes of systemic treatments for plaque psoriasis.</p><p><strong>Methods: </strong>Databases were searched from inception through June 1, 2023. We conducted duplicate study selection, data extraction, bias assessment risk, and NMA evidence certainty assessment and analyses. Outcomes included proportion of participants achieving Psoriasis Area and Severity Index (PASI) 75 and/or 90 and those with (1) total cardiovascular events, (2) major adverse cardiovascular events (MACE), (3) other cardiovascular events, and (4) total renal events.</p><p><strong>Results: </strong>We included 68 randomized clinical trials (n = 34,414 patients). Compared with placebo, bimekizumab (odds ratio [OR] 101.12, 95% confidence interval [CI] 34.26-301.46, surface under the cumulative ranking curve [SUCRA] 27, high certainty) was the top treatment demonstrating better PASI 75 and had reduced total cardiovascular events (OR 0.06, 95% CI 0-0.80, SUCRA 89, moderate certainty). Ixekizumab (OR 86.92, 95% CI 39.06-199.66, SUCRA 15, high certainty) showed better PASI 90 rates but was associated with increased MACE over placebo (OR 3.26, 95% CI 1.26-9.31, SUCRA 26, high certainty) and bimekizumab (OR 31.92, 95% CI 2.01, 1123.25), moderate certainty). Renal outcomes were similar among groups.</p><p><strong>Conclusion: </strong>Bimekizumab showed better therapeutic efficacy scores and safety profile than other agents. Ixekizumab may increase cardiovascular risk and should be used with caution. Reliable long-term safety data of the treatments analyzed here require assessing non-randomized studies and examining postmarketing reports from regulatory agencies.</p><p><strong>Trial registration: </strong>PROSPERO (CRD42022381489).</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2455-2482"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-19DOI: 10.1007/s13555-025-01495-y
Zoe D Draelos, Kizito Kyeremateng, Nicholas Squittieri
{"title":"Reduction in Facial Sebum Production Following Treatment with Clascoterone Cream 1% in Patients with Acne Vulgaris: 12-Week Interim Analysis.","authors":"Zoe D Draelos, Kizito Kyeremateng, Nicholas Squittieri","doi":"10.1007/s13555-025-01495-y","DOIUrl":"10.1007/s13555-025-01495-y","url":null,"abstract":"<p><strong>Introduction: </strong>In vitro, clascoterone inhibits androgen-induced sebum production-a key driver of acne pathogenesis-although the exact mechanism of action of clascoterone for the treatment of acne is unknown. This study evaluated reductions in casual sebum production following 12 weeks of clascoterone cream 1% treatment in patients with acne.</p><p><strong>Methods: </strong>Patients ≥ 12 years old with mild-to-moderate acne applied clascoterone cream 1% twice daily for 12 weeks. The primary endpoint was the reduction in casual sebum measurements at Week 12. Additional endpoints included Investigator's Global Assessment (IGA) score, inflammatory and noninflammatory lesion counts (ILC and NILC), and tolerability. Data were analyzed using Student's t-test and Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Forty patients with a mean age of 20.9 years were enrolled, all of whom completed Week 12. Significant percentage reductions from baseline were observed in sebum measurements (27%), ILC (54%), and NILC (34%; all p < 0.001), and patients achieved a 29% reduction in IGA score. No tolerability or safety issues were identified during the 12-week interim analysis period.</p><p><strong>Conclusion: </strong>Clascoterone cream 1% led to significant reductions in sebum measurements with improvements in acne severity and was well tolerated.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT06415279.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2657-2666"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-18DOI: 10.1007/s13555-025-01487-y
Amit Garg, Jennifer Hsiao, Martina L Porter, Vivian Shi
{"title":"Current Treatments and Future Directions for Hidradenitis Suppurativa: a Narrative Review of Completed and Ongoing Phase 3 Clinical Trials of Biologic Therapies.","authors":"Amit Garg, Jennifer Hsiao, Martina L Porter, Vivian Shi","doi":"10.1007/s13555-025-01487-y","DOIUrl":"10.1007/s13555-025-01487-y","url":null,"abstract":"<p><p>Hidradenitis suppurativa (HS) is a chronic, progressive inflammatory disease characterized by recurrent nodules, abscesses, draining tunnels, and scarring. Current treatment strategies for patients with HS typically involve a combination of therapeutic and surgical interventions that are tailored to the severity and extent of the disease. Treatment of patients with mild disease often includes topical or systemic antibiotics followed by anti-androgen therapies; however, these treatments are off-label and are generally only modestly effective for patients with moderate-to-severe disease. The lack of dedicated therapies targeting pathogenic mechanisms of HS has historically contributed to the unmet needs for disease management. These needs have been addressed recently by the emergence of biologic therapies, which can provide rapid and sustained symptom and disease control for patients who have poor treatment responses to initial therapies and progressive disease. Biologics have become an integral component in treatment strategies for patients with HS, but the unique clinical benefits and safety profile of each biologic can impact treatment decisions for individual patients. Recent elucidation of unique immunological pathways that contribute to HS pathophysiology may lead to the development of novel therapeutics that would expand the current therapeutic options, especially for patients with advanced disease. The purpose of this review is to provide an overview of the present therapeutic landscape for HS, with a particular focus on the mechanism of action, efficacy, and safety of biologic therapies either approved or under clinical investigation for the treatment of patients with HS. We also provide expert commentary on future directions of HS therapies as they pertain to recent research on the immunopathology of HS.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2361-2377"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354412/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dermatology and TherapyPub Date : 2025-09-01Epub Date: 2025-07-14DOI: 10.1007/s13555-025-01485-0
Jonathan I Silverberg, Melinda Gooderham, Norito Katoh, Valeria Aoki, Andrew E Pink, Yousef Binamer, Brad Glick, Petra Staubach, Brian Calimlim, Chao Li, Ayman Grada, Alvaro Moreira, Wan-Ju Lee, Andreas Wollenberg
{"title":"Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2).","authors":"Jonathan I Silverberg, Melinda Gooderham, Norito Katoh, Valeria Aoki, Andrew E Pink, Yousef Binamer, Brad Glick, Petra Staubach, Brian Calimlim, Chao Li, Ayman Grada, Alvaro Moreira, Wan-Ju Lee, Andreas Wollenberg","doi":"10.1007/s13555-025-01485-0","DOIUrl":"10.1007/s13555-025-01485-0","url":null,"abstract":"<p><strong>Introduction: </strong>The Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines recommend achieving minimal disease activity (MDA) in atopic dermatitis (AD), defined as simultaneous achievement of optimal treatment targets for at least one clinician- and one patient-reported outcome (ClinRO + PRO). We assessed the effect of upadacitinib on achieving optimal ClinROs, optimal PROs, and MDA in Measure Up 1 (NCT03569293) and Measure Up 2 (NCT3607422) studies for patients with moderate to severe AD.</p><p><strong>Methods: </strong>Patients were randomized to receive upadacitinib (15 mg or 30 mg) or placebo. Achievement of ≥ 1 optimal target in ClinROs, ≥ 1 optimal target in PROs, and MDA (≥ 1 optimal ClinROs and ≥ 1 optimal PROs) were reported at weeks 16 (upadacitinib vs placebo) and 52 (upadacitinib only). MDAs in selected combinations were also assessed at weeks 16 and 52. A total of 1683 and 1124 patients were included in the week 16 and 52 analysis, respectively.</p><p><strong>Results: </strong>At week 16, a significantly higher proportion of patients receiving upadacitinib (15 mg: 42.5%, 30 mg: 55.9%) compared with placebo (6.4%) achieved MDA. At week 52, 57.4% and 69.9% of patients receiving 15 mg and 30 mg of upadacitinib achieved MDA, respectively. Specifically, patients receiving upadacitinib attained higher rates of ≥ 90% reduction from baseline in Eczema Area and Severity Index (EASI 90) + Worst Pruritus-Numerical Rating Scale (WP-NRS) 0/1 at week 16 (15 mg: 25.3%, 30 mg: 39.4% vs placebo: 1.8%) and maintained at week 52 (15 mg: 38.1%, 30 mg: 46.9%).</p><p><strong>Conclusion: </strong>Treatment with upadacitinib achieved both ClinRO and PRO optimal treatment targets as well as MDA and may optimize overall disease management in patients with moderate-to-severe AD.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":"2583-2594"},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12354932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144625593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}