Treatment Satisfaction, Efficacy, and Safety of Delgocitinib Ointment for Atopic Dermatitis-Induced Rash on the Face and Neck: Efficacy at Reducing Local Side Effects of Topical Steroid and Tacrolimus Ointment

IF 2.7 3区医学 Q2 DERMATOLOGY

Journal of Dermatology Pub Date : 2025-06-26 DOI:10.1111/1346-8138.17817

Masatoshi Abe, Atsuyuki Igarashi, Hiroyuki Kitajima, Hiroyuki Toyama, Kenji Kabashima, Hidehisa Saeki

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Abstract

This open-label, single-arm, multicenter clinical study evaluated the treatment satisfaction, efficacy, and safety of 0.5% delgocitinib ointment twice daily for 12 weeks, applied to face/neck lesions caused by ≥ 3 months use of topical steroids or tacrolimus ointment in patients with atopic dermatitis (AD). The primary endpoint was change in treatment satisfaction (Treatment Satisfaction Questionnaire for Medication-9 [TSQM-9]). Secondary endpoints included changes in modified Eczema Area and Severity Index (mEASI) and EASI scores, the numerical rating scale (NRS) for pruritus, the severity of side effects, skin condition at target lesions, disease control (Atopic Dermatitis Control Tool [ADCT]), and preference for delgocitinib ointment (Patient Preference Questionnaire [PPQ]). Overall, 38 patients (mean age 40 years) with a duration of AD of 30.7 years were included in the study. Scores of TSQM-9 for global satisfaction (Week 0: 58.8 ± 14.7; Week 4: 68.5 ± 16.6; Week 12: 73.2 ± 16.0), effectiveness (57.0 ± 14.1; 67.0 ± 12.6; 70.9 ± 13.4), and convenience (64.9 ± 15.0; 73.6 ± 12.7; 76.1 ± 13.6) (all cases p < 0.01), mEASI (Week 0: 1.31; Week 12: 0.68, p < 0.001) and NRS (4.53; 2.71, p < 0.001) scores, and ADCT (8.3; 5.6, p < 0.01) were improved significantly. Compared with that at Week 0, the incidence of ≥ mild skin atrophy, telangiectasia, and skin irritation decreased. The PPQ showed that approximately 80% of patients rated all queries as “strongly agree” or “agree.” In addition, skin conditions were significantly improved for all items (dryness, feel, firmness/elasticity, and appearance) at 1–2 weeks and 12 weeks (p < 0.001). The present results demonstrate that delgocitinib ointment might be an effective option for switching treatment for face/neck AD in patients with skin lesions, or for those who are concerned about the development of side effects related to steroids or tacrolimus.

Trial Registration: Japan Registry of Clinical Trials (jRCTs031230063)

Abstract Image

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Delgocitinib软膏治疗面部和颈部特应性皮炎引起的皮疹的疗效、疗效和安全性：减轻局部类固醇和他克莫司软膏局部副作用的疗效。

这项开放标签、单臂、多中心临床研究评估了0.5%德尔西替尼软膏的治疗满意度、疗效和安全性，每日两次，持续12周，用于特应性皮炎（AD）患者因外用类固醇或他克莫司软膏≥3个月引起的面部/颈部病变。主要终点为治疗满意度的变化（治疗满意度问卷-9 [TSQM-9]）。次要终点包括改良湿疹面积和严重程度指数（mEASI）和EASI评分的变化，瘙痒的数值评定量表（NRS），副作用的严重程度，目标病变的皮肤状况，疾病控制（特应性皮炎控制工具[ADCT]），以及对德戈西替尼软膏的偏好（患者偏好问卷[PPQ]）。研究共纳入38例AD患者（平均年龄40岁），病程30.7年。TSQM-9整体满意度评分(第0周：58.8±14.7；第四周：68.5±16.6；第12周：73.2±16.0)，有效性(57.0±14.1；67.0±12.6；70.9±13.4)，便利性(64.9±15.0；73.6±12.7；76.1±13.6)(所有病例p

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来源期刊

Journal of Dermatology 医学-皮肤病学

CiteScore

4.60

自引率

9.70%

发文量

368

审稿时长

4-8 weeks

期刊介绍： The Journal of Dermatology is the official peer-reviewed publication of the Japanese Dermatological Association and the Asian Dermatological Association. The journal aims to provide a forum for the exchange of information about new and significant research in dermatology and to promote the discipline of dermatology in Japan and throughout the world. Research articles are supplemented by reviews, theoretical articles, special features, commentaries, book reviews and proceedings of workshops and conferences. Preliminary or short reports and letters to the editor of two printed pages or less will be published as soon as possible. Papers in all fields of dermatology will be considered.