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Data wobbles in hidradenitis suppurativa clinical trials and potential contributing factors: a retrospective review. 化脓性扁桃体炎临床试验中的数据波动及潜在诱因:回顾性研究。
Q2 Medicine Pub Date : 2024-06-07 eCollection Date: 2024-06-01 DOI: 10.1097/JW9.0000000000000152
Corey L Snyder, Ruby S Gibson, Stella X Chen, Martina L Porter, Alexa B Kimball

Background: In some hidradenitis suppurativa (HS) clinical trial study arms, there is an unexpected decline in efficacy between the penultimate visit and the prespecified primary endpoint week, which we have termed a "wobble."

Objective: We aimed to establish how often study arms in HS programs wobble.

Methods: In a retrospective review, we identified HS clinical trials listed on ClinicalTrials.gov testing systemic, nonantibiotic medications that utilized Hidradenitis Suppurativa Clinical Response (HiSCR) as an outcome measure. We identified study arms demonstrating greater improvement in a visit prior to the primary endpoint week. Baseline subject characteristics were compared between studies with HiSCR wobble and no HiSCR wobble.

Results: A total of 21 studies (randomized control trial [RCT], n = 14; open-label, n = 7) with 35 study drug arms (RCT, n = 27; open-label, n = 8) and 14 placebo arms were identified. HiSCR wobble occurred significantly more often in RCT compared to open-label study drug arms (11/27 [40.7%] vs 0/8 [0%]). In RCT study arms with HiSCR wobble, baseline draining fistula counts were significantly lower (2.3 vs 3.2), and numerically fewer Hurley stage 3 patients (33.2% vs 42.5%), lower weighted total abscess and nodule counts (12.1 vs 12.6), lower weighted dermatology life quality index scores (12.5 vs 14.5), and a higher proportion of female patients (63.9% vs 58.3%) were observed.

Limitations: Include low number of HS clinical trials and insufficient data reported in many studies to assess for wobble, degree of wobble, and to compare all baseline characteristics.

Conclusion: Nonlinear improvement in study arm response occurs in some HS RCTs. Potential contributing factors include a higher proportion of less severe patients at baseline and more female patients.

背景:在一些化脓性扁桃体炎(HS)临床试验的研究臂中,从倒数第二次访视到预设的主要终点周之间,疗效会出现意想不到的下降,我们称之为 "摇摆":我们旨在确定在 HS 项目中,研究臂发生摇摆的频率:在一项回顾性研究中,我们确定了ClinicalTrials.gov网站上列出的HS临床试验,这些试验测试了使用HiSCR(Hidradenitis Suppurativa Clinical Response)作为结果测量指标的全身性非抗生素药物。我们确定了在主要终点周之前的访问中显示出更大改善的研究臂。比较了有 HiSCR 波动和无 HiSCR 波动的研究的基线受试者特征:共确定了 21 项研究(随机对照试验 [RCT],n = 14;开放标签,n = 7),35 个研究药物臂(RCT,n = 27;开放标签,n = 8)和 14 个安慰剂臂。与开放标签研究用药臂(11/27 [40.7%] vs 0/8 [0%])相比,RCT 研究用药臂发生 HiSCR 摇晃的频率明显更高。在出现 HiSCR 波动的 RCT 研究臂中,基线引流瘘计数明显较低(2.3 vs 3.2),Hurley 3 期患者数量较少(33.2% vs 42.5%),加权总脓肿和结节计数较低(12.1 vs 12.6),加权皮肤科生活质量指数评分较低(12.5 vs 14.5),女性患者比例较高(63.9% vs 58.3%):局限性:包括HS临床试验的数量较少,许多研究报告的数据不足以评估摇摆、摇摆程度和比较所有基线特征:结论:在一些 HS RCT 中,研究臂反应出现了非线性改善。可能的原因包括基线时病情较轻的患者比例较高,以及女性患者较多。
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引用次数: 0
Spironolactone in hidradenitis suppurativa: a single-center. 螺内酯治疗化脓性扁桃体炎:一个单一中心。
Q2 Medicine Pub Date : 2024-03-19 eCollection Date: 2024-03-01 DOI: 10.1097/JW9.0000000000000135
Rahul Masson, Sarah E Park, Terri Shih, Marcia Hogeling, Vivian Y Shi, Jennifer L Hsiao
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引用次数: 0
Evaluating patients with hidradenitis suppurativa for disordered eating. 评估化脓性扁桃体炎患者的饮食失调。
Q2 Medicine Pub Date : 2024-03-07 eCollection Date: 2024-03-01 DOI: 10.1097/JW9.0000000000000138
Amina Ziad, Yiwen Helen Li, Kristin N Javaras, Karla Santiago-Soltero, Alexandra Charrow
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引用次数: 0
Global facial rejuvenation with one treatment of incobotulinumtoxinA, hyaluronic acid, and calcium hydroxyapatite results in long-term patient-reported satisfaction. 采用肉毒杆菌毒素、透明质酸和羟基磷灰石钙的综合治疗,可使患者长期满意。
Q2 Medicine Pub Date : 2023-11-22 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000124
Jasmine Thai Lu, Kachiu C Lee

Background: Global facial rejuvenation using injectables (neuromodulators and fillers) has reported patient satisfaction after 2 treatments: an initial and touch-up treatment at 2-4 weeks afterward. In practice, patients typically receive only 1 treatment and do not return for a touch-up treatment within a month.

Objective: The purpose of this study was to assess patient-reported satisfaction after only 1 treatment, thus mimicking real-world scenarios.

Methods: Patients with facial photoaging (Glogau facial aging scale ≥2) were treated with calcium hydroxyapatite, hyaluronic acid 22.5 mg/mL, and incobotulinumtoxinA injections for full facial rejuvenation, with no touch-up treatments. Patients completed the FACE-Q Satisfaction with Facial Appearance survey at baseline and 1- and 3-month post-treatment. The treating physician completed the Global Aesthetic Improvement Scale at 1- and 3-month post-treatment.

Results: Twenty-two patients were enrolled in the study, with 1 patient lost to follow-up. There was a significant improvement in mean FACE-Q scores at 1-month (80.1, P = .01) and 3-month (77.9, P = .02) compared to baseline (71.4). Mean Global Aesthetic Improvement Scale scores at 1-month (2.1) and 3-month (2.2) were not statistically significant, indicating sustained improvement at 3 months. The product amount used per patient varied and was not correlated with either score. Limitations included a lack of a control group and follow-up ending at 3 months. Strengths included assessment of patient satisfaction after only 1 treatment, compared to other studies allowing 2 treatments.

Limitations: Limitations include a small sample size and lack of a control group.

Conclusion: Global full facial rejuvenation using 1 treatment of calcium hydroxyapatite, hyaluronic acid 22.5 mg/mL, and incobotulinumtoxinA provides sustained patient-reported satisfaction at 3 months.

背景:使用注射剂(神经调节剂和填充剂)进行全面面部年轻化治疗的患者在两种治疗后满意:初始治疗和2-4周后的补充治疗。实际上,患者通常只接受一次治疗,并且在一个月内不会返回进行补充治疗。目的:本研究的目的是评估患者在仅仅一次治疗后的满意度,从而模拟现实世界的情况。方法:面部光老化(Glogau面部老化分级≥2级)患者采用羟基磷灰石钙、透明质酸22.5 mg/mL、肉毒杆菌毒素注射治疗面部全年轻化,不进行补肤治疗。患者在基线和治疗后1个月和3个月完成FACE-Q面部外观满意度调查。治疗医师分别于治疗后1个月和3个月完成整体审美改善量表。结果:22例患者入组,1例患者失访。与基线(71.4)相比,1个月(80.1,P = 0.01)和3个月(77.9,P = 0.02)的平均FACE-Q评分有显著改善。1个月(2.1)和3个月(2.2)的全球美学改善量表平均得分无统计学意义,表明3个月时持续改善。每位患者使用的产品量各不相同,与两种评分无关。局限性包括缺乏对照组和随访时间为3个月。优势包括仅在1次治疗后评估患者满意度,而其他研究允许2次治疗。局限性:局限性包括样本量小和缺乏对照组。结论:采用羟基磷灰石钙、透明质酸22.5 mg/mL和肉毒杆菌毒素1次治疗可在3个月后提供持续的患者满意度。
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引用次数: 0
Venture capital funding of dermatology companies founded by women: a unique set of challenges. 女性创办的皮肤病公司的风险投资:一系列独特的挑战。
Q2 Medicine Pub Date : 2023-11-22 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000120
Amar D Desai, Jacquelyn M Roth, Nilesh Kodali, Simona Alomary, Rahul Bhatia, Vinod E Nambudiri, Cindy Wassef, Shari R Lipner
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引用次数: 0
Understanding perceptions of hair loss in hijab-wearing women: a pilot survey study. 了解对戴头巾妇女脱发的看法:一项试点调查研究。
Q2 Medicine Pub Date : 2023-11-16 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000115
Lina Alhanshali, Fatima Bawany, Michael G Buontempo, Jerry Shapiro, Kristen Lo Sicco
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引用次数: 0
Young women in sororities more likely to have used tanning beds and report improved appearance and self-confidence with tan skin. 姐妹会的年轻女性更有可能使用晒黑床,并报告晒黑后的皮肤改善了她们的外表和自信。
Q2 Medicine Pub Date : 2023-11-16 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000116
Jazmin Newton, Allen Wellman, Lauren Ochoa, Alyssa Reinschmidt, Samuel John Vassar, Minga Vargas, DenYelle B Kenyon, Marcus Frohm
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引用次数: 0
Gender perspective in psoriasis: a scoping review and proposal of strategies for improved clinical practice by European dermatologists. 银屑病的性别观点:欧洲皮肤科医生对改善临床实践策略的范围审查和建议。
Q2 Medicine Pub Date : 2023-11-01 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000112
Alvaro Gonzalez-Cantero, María Magdalena Constantin, Annunziata Dattola, Tom Hillary, Elise Kleyn, Nina Magnolo

Background: The prevalence of psoriasis is similar between men and women; however, evidence exists of sex- and gender-related differences in disease expression, impact, coping, and needs of patients with psoriasis. These differences are essential and should be considered in clinical practice and research.

Objective: To compile available evidence on sex- and gender-related differences in psoriasis, identify the most critical gaps in clinical practice and research, and use it to propose strategies for improved clinical practice.

Methods: Six European dermatologists selected the topics to consider according to their relevance in the dermatology setting with the support of methodologists. Evidence on sex- and gender-related differences was obtained by a scoping review based on search strategies in Medline and Cochrane Library from inception to October 2021 using the following terms: arthritis, psoriatic, psoriasis, gender, and sex. The panel discussed the results and proposed strategies by consensus.

Results: The scoping review identified broad themes: (1) clinical expression, (2) severity and patient-reported outcomes, (3) psychosocial impact, (4) access to treatments and propensity to treat, (5) comorbidities, and (6) treatment effect. The strategies are based on these broad themes.

Limitations: No risk of bias assessment was done due to the scoping nature of the review.

Conclusion: This review offers insights into gender differences in psoriasis, providing a foundation for improving clinical practice and patient outcomes.

背景:银屑病的患病率在男性和女性之间相似;然而,有证据表明银屑病患者在疾病表达、影响、应对和需求方面存在性别和性别相关的差异。这些差异是至关重要的,应该在临床实践和研究中加以考虑。目的:收集银屑病性别和性别相关差异的现有证据,找出临床实践和研究中最关键的差距,并利用这些差距提出改进临床实践的策略。方法:六名欧洲皮肤科医生在方法学家的支持下,根据其在皮肤科环境中的相关性选择了要考虑的主题。从成立到2021年10月,基于Medline和Cochrane图书馆的搜索策略,通过范围界定审查获得了性别和性别相关差异的证据,使用了以下术语:关节炎、银屑病、银屑病、性别和性别。小组以协商一致方式讨论了结果并提出了战略建议。结果:范围界定审查确定了广泛的主题:(1)临床表现,(2)严重程度和患者报告的结果,(3)心理社会影响,(4)获得治疗的机会和治疗倾向,(5)合并症,以及(6)治疗效果。这些战略基于这些广泛的主题。局限性:由于审查的范围界定性质,没有进行偏见评估的风险。结论:这篇综述为银屑病的性别差异提供了见解,为改善临床实践和患者预后提供了基础。
{"title":"Gender perspective in psoriasis: a scoping review and proposal of strategies for improved clinical practice by European dermatologists.","authors":"Alvaro Gonzalez-Cantero, María Magdalena Constantin, Annunziata Dattola, Tom Hillary, Elise Kleyn, Nina Magnolo","doi":"10.1097/JW9.0000000000000112","DOIUrl":"10.1097/JW9.0000000000000112","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of psoriasis is similar between men and women; however, evidence exists of sex- and gender-related differences in disease expression, impact, coping, and needs of patients with psoriasis. These differences are essential and should be considered in clinical practice and research.</p><p><strong>Objective: </strong>To compile available evidence on sex- and gender-related differences in psoriasis, identify the most critical gaps in clinical practice and research, and use it to propose strategies for improved clinical practice.</p><p><strong>Methods: </strong>Six European dermatologists selected the topics to consider according to their relevance in the dermatology setting with the support of methodologists. Evidence on sex- and gender-related differences was obtained by a scoping review based on search strategies in Medline and Cochrane Library from inception to October 2021 using the following terms: arthritis, psoriatic, psoriasis, gender, and sex. The panel discussed the results and proposed strategies by consensus.</p><p><strong>Results: </strong>The scoping review identified broad themes: (1) clinical expression, (2) severity and patient-reported outcomes, (3) psychosocial impact, (4) access to treatments and propensity to treat, (5) comorbidities, and (6) treatment effect. The strategies are based on these broad themes.</p><p><strong>Limitations: </strong>No risk of bias assessment was done due to the scoping nature of the review.</p><p><strong>Conclusion: </strong>This review offers insights into gender differences in psoriasis, providing a foundation for improving clinical practice and patient outcomes.</p>","PeriodicalId":53478,"journal":{"name":"International Journal of Women''s Dermatology","volume":"9 4","pages":"e112"},"PeriodicalIF":0.0,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10615520/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71429135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical and phototrichogrammatic evaluation of estradiol replacement therapy on hair growth in postmenopausal Japanese women with female pattern hair loss: a pilot study. 雌二醇替代疗法对绝经后日本女性脱发妇女头发生长的临床和光富集图评估:一项初步研究。
Q2 Medicine Pub Date : 2023-11-01 eCollection Date: 2023-12-01 DOI: 10.1097/JW9.0000000000000109
Yujiro Endo, Yuko Obayashi, Michiaki Murakoshi, Juichiro Saito, Rie Ueki

Background: Female pattern hair loss (FPHL) is known to present with characteristic pathological conditions, including reduced overall hair density. Female hormones affect hair condition; however, the detailed mechanism is unknown. Furthermore, research on the topic is complicated by the fact that senescent alopecia often occurs concurrently with FPHL. Therefore, we investigated the effect of estradiol, a female hormone, on hair growth by eliminating aging factors and objectively evaluating hair changes caused by female hormone replacement therapy (HRT).

Objective: This study was conducted to elucidate the mechanism through which female hormones exert their effects on hair.

Methods: The study included 11 female patients undergoing HRT who were evaluated before initiating HRT, 3 months after initiating HRT, and 6 months after initiating HRT. The thinning hair score, hair density, telogen hair rate, telogen plucking strength, hair growth rate, and hair thickness were measured and evaluated. Furthermore, hematological tests were performed to assess the general physical condition of the participants.

Results: HRT increased the telogen hair rate (P = .010, paired t test) at 3 months, improved frontal hairline thinning score (P = .008, Wilcoxon test), and increased the plucking strength (P = .013, paired t test) at 6 months.

Limitations: The limitation of this study included the relatively small sample size, inability to conduct further long-term tests because of participant burden, and lack of a control group.

Conclusion: The results suggested that HRT improved the appearance of the frontal hairline. As few studies have analyzed the effects of female hormones on human hair, a novel finding of this study was the effects of estradiol on the plucking strength after excluding age as a factor. We believe that these findings will contribute to understanding FPHL and developing female hormone-related treatments.

背景:已知女性型脱发(FPHL)具有特征性的病理状况,包括整体头发密度降低。女性荷尔蒙会影响头发状况;然而,具体机制尚不清楚。此外,衰老性脱发经常与FPHL同时发生,这一事实使该主题的研究变得复杂。因此,我们通过消除衰老因素和客观评估女性激素替代疗法(HRT)引起的头发变化来研究雌二醇(一种女性激素)对头发生长的影响。目的:阐明女性激素对头发影响的机制。方法:该研究包括11名接受HRT的女性患者,她们在开始HRT前、开始HRT后3个月和开始HRT后六个月接受评估。测量并评估稀疏毛发评分、毛发密度、休止期毛发率、休止期拔毛强度、毛发生长率和毛发厚度。此外,还进行了血液学检查,以评估参与者的总体身体状况。结果:HRT在3个月时增加了休止期毛发率(P=0.010,配对t检验),在6个月时改善了额部发际线稀疏评分(P=0.008,Wilcoxon检验),并增加了拔毛强度(P=0.013,配对t试验)。局限性:这项研究的局限性包括样本量相对较小,由于参与者负担而无法进行进一步的长期测试,以及缺乏对照组。结论:HRT改善了额部发际线的外观。由于很少有研究分析女性激素对人类头发的影响,本研究的一个新发现是,在排除年龄因素后,雌二醇对拔毛强度的影响。我们相信这些发现将有助于理解FPHL和开发女性激素相关的治疗方法。
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引用次数: 0
Considerations and recommendations on camouflage in alopecia in Black women. 关于黑人女性脱发伪装的考虑和建议。
Q2 Medicine Pub Date : 2023-10-04 eCollection Date: 2023-10-01 DOI: 10.1097/JW9.0000000000000111
Marta Taye, Nourine Ahmed Kamili, Crystal Aguh, Loren D Krueger

Alopecia is among the leading dermatological concerns affecting Black women. For many women, hair is a central component of identity and self-expression, the loss of which can have significant psychosocial effects. Hair camouflage is often utilized to minimize the visibility of hair loss, provide aesthetic benefits, and improve quality of life. The versatility and affordability of hair camouflage allows patients with alopecia to conceal hair loss, increasing self-confidence, and decreasing social stigma. However, hair camouflage practices often involve adhesives, chemicals, and/or high-tension braiding, all of which can exacerbate alopecia. Accordingly, special considerations should be made to protect patients' natural hair from damage while using these styling practices. A better understanding of best practices for some of the most widely used camouflage options-wigs, extensions, topical hair fibers, and micropigmentation-can help clinicians establish rapport with Black women and optimize individually-tailored therapeutic plans during active treatment and end-stage hair loss.

脱发是影响黑人女性的主要皮肤病问题之一。对许多女性来说,头发是身份和自我表达的核心组成部分,失去头发会产生重大的社会心理影响。头发伪装通常被用来最大限度地减少脱发的可见性,提供美学益处,并提高生活质量。头发伪装的多功能性和可负担性使脱发患者能够掩盖脱发,增强自信,减少社会耻辱感。然而,伪装头发的做法通常涉及粘合剂、化学品和/或高压编织,所有这些都会加剧脱发。因此,在使用这些造型方法时,应特别注意保护患者的自然头发不受损伤。更好地了解一些最广泛使用的伪装选项——假发、假发、局部头发纤维和微色素沉着——的最佳实践,可以帮助临床医生与黑人女性建立融洽的关系,并在积极治疗和终末期脱发期间优化个性化的治疗计划。
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引用次数: 0
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International Journal of Women''s Dermatology
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