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.

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).