Abe Masatoshi, Igarashi Atsuyuki, Kitajima Hiroyuki, Toyama Hiroyuki, Kabashima Kenji, Saeki Hidehisa
Kojinkai Sapporo Skin Clinic, Sapporo, Japan.
Igarashi Dermatology Higashigotanda, Tokyo, Japan.
J Dermatol. 2025 Aug;52(8):1232-1242. doi: 10.1111/1346-8138.17817. Epub 2025 Jun 26.
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).
本开放性、单臂、多中心临床研究评估了0.5%的地氯雷他定软膏每日两次、连续使用12周，用于治疗特应性皮炎（AD）患者因使用外用糖皮质激素或他克莫司软膏≥3个月导致的面部/颈部皮损的治疗满意度、疗效及安全性。主要终点为治疗满意度的变化（药物治疗满意度问卷-9 [TSQM-9]）。次要终点包括改良湿疹面积和严重程度指数（mEASI）及EASI评分的变化、瘙痒数字评定量表（NRS）、副作用严重程度、靶皮损处的皮肤状况、疾病控制情况（特应性皮炎控制工具[ADCT]）以及对地氯雷他定软膏的偏好（患者偏好问卷[PPQ]）。该研究共纳入38例患者（平均年龄40岁），AD病程为30.7年。TSQM-9的总体满意度评分（第0周：58.8±14.7；第4周：68.5±16.6；第12周：73.2±16.0）、有效性评分（57.0±14.1；67.0±12.6；70.9±13.4）和便利性评分（64.9±15.0；73.6±12.7；76.1±13.6）（所有病例p<0.01），mEASI评分（第0周：1.31；第12周：0.68，p<0.001）和NRS评分（4.53；2.71，p<0.001）以及ADCT评分（8.3；5.6，p<0.01）均显著改善。与第0周相比，≥轻度皮肤萎缩、毛细血管扩张和皮肤刺激的发生率降低。PPQ显示，约80%的患者对所有问题的回答为“强烈同意”或“同意”。此外，在第1 - 2周和第12周时，所有项目（干燥、触感、紧致度/弹性和外观）的皮肤状况均显著改善（p<0.001）。目前的结果表明，对于有皮肤损害的AD患者或担心与糖皮质激素或他克莫司相关副作用的患者，地氯雷他定软膏可能是面部/颈部AD转换治疗的有效选择。试验注册：日本临床试验注册中心（jRCTs031230063）
