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Evaluation of treatment satisfaction after switching from topical steroid to delgocitinib ointment-dominated treatment for skin rashes on the trunk and limbs in atopic dermatitis.

Evaluation of treatment satisfaction after switching to delgocitinib ointment for trunk and limbs rash in atopic dermatitis.

101

101 patents (44 males, 57 females), mean age 35.1 years (males: 34.2 years, females: 35.8 years), who provided written informed consent, were enrolled in this clinical study. The mean age of the study participants at enrollment was 34.9+-12.5 years, and the mean duration of atopic dermatitis (AD) was 21.4+-13.8 years. There were no significant differences in these background characteristics between males and females. The mean EASI score was 9.60+-8.82, and the mean mEASI score for the trunk and extremities was 8.82+-8.22.

93 patients were included in the analysis, excluding 1 patient who withdrew consent after enrollment, 1 patient who did not attend the clinic after enrollment, 4 patients who violated eligibility criteria due to the use of prohibited concomitant medications, and 2 patients who met the exclusion criteria. 5 patients discontinued the study due to exacerbation of skin lesions: 4 due to exacerbation of facial and neck lesions, and 1 due to exacerbation of lesions on other parts of the body. No clear trends were observed in the background characteristics, prior treatments, or disease severity among the 5 patients who discontinued the study.

There was 1 AE (SE) considered to be related to this clinical study (folliculitis) in one patient. This event did not affect the continuation of the study and was resolved. Eighteen other adverse events occurred; however, none were considered related to this study, and none caused any problems in the clinical course.

Primary endpoint: Treatment satisfaction (TSQM-9) Changes in the TSQM-9 score from week 0 (baseline) to week 12 after the start of treatment showed significant improvement in overall satisfaction and satisfaction with convenience at week 12 compared to baseline, indicating improved treatment satisfaction. Although there was no significant difference in satisfaction with effectiveness, an increasing trend was observed. Secondary endpoints Changes in skin lesions and pruritus: Switching to delgocitinib ointment showed a significant improvement in skin lesions (EASI score, mEASI score) and pruritus (NRS score) over time after the start of treatment. Patient control: Assessment using the ADCT showed that switching to delgocitinib ointment maintained good disease control throughout the observation period. Local side effects: Local side effects such as skin atrophy and telangiectasia observed with previous treatments were significantly reduced by switching to delgocitinib ointment. Improvement was also observed in rosacea-like dermatitis and erythema. Treatment preference and skin condition: Many patients felt that delgocitinib ointment was more effective, easier to use, and had fewer side effects. Significant improvements were also observed in various aspects of skin condition, including dryness, texture, firmness/elasticity, and appearance.

This study assessed the effectiveness of switching from topical corticosteroids to delgocitinib ointment in AD patients with trunk and extremity lesions. Delgocitinib showed positive results in improving lesions, reducing side effects, and increasing patient satisfaction. This suggests delgocitinib is a good option for AD patients with trunk and extremity lesions experiencing side effects from topical corticosteroid use.

Mar. 01, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs031230102

Abe Masatoshi

Sapporo Dermatology Clinic

2-1-1, Minami3jonishi, Chuuou-ku, Sapporo-shi, Hokkaido

masaabe@kojinkai.org

Ryoichi Taguchi

EBC&M LLC

ShibaMatsuo Building 4F, 2-9-1, Shibakoen, Minato-ku, Tokyo, Japan

+81-3-6435-3833

ryoichi_taguchi@ebc-m.com

Complete

May. 29, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients aged 18 years and older with atopic dermatitis when obtaining consent.
(2) Patients using topical steroids for trunk or limb rash for more than 3 months.
(3) Patients with local side effects such as skin atrophy or telangiectasia due to the use of topical steroids on the trunk or limb or who are expected to use topical steroids for a long time and are concerned about the development of local side effects.
(4) Patients whose trunk and limbs are being treated with topical steroids and are considered treatable with a maximum of 5 g of delgocitinib ointment per dose (within approximately 30% of body surface area, taking into account body size).
(5) Patients who have given written consent to participate in the study.
**: Any rank and formulation of topical steroids.

(1) Patients using the strongest topical steroids. Using clobetasol propionate shampoo on the scalp is allowed.
(2) Patients using delgocitinib ointment or difamilast ointment.
(3) Patients with plaque or other erosions forming obvious foci at the site of application of studied drug.
(4) Patients who are pregnant, may become pregnant, or plan to become pregnant during the study period.
(5) Patients who are breastfeeding
(6) Patients previously treated with delgocitinib ointment
(7) Patients receiving systemic therapy with internal medications (steroids, cyclosporine, JAK inhibitors) at the time of obtaining consent or within the last 3 months.
(8) Patients receiving systemic therapy with biologics (e.g., dupilumab, nemolizumab) at the time of obtaining consent or within the last 6 months
(9) Patients receiving phototherapy, such as ultraviolet light therapy, at the time of obtaining consent or within the last 3 months.
(10) Patients who have participated in a clinical trial or similar within the last 6 months
(11) Patients deemed ineligible for the study by the investigator or others.

Both

Atopic dermatitis

Delgocitinib Ointment 0.5% (CORECTIM Ointment 0. 5%) will be applied topically twice daily for 4 weeks, limited to the area of the rash; if it is considered possible to increase the area of application at the 4-week visit, the maximum amount of study drug applied per dose will be limited to 5 g and the maximum amount applied to the trunk and limbs will be limited to 30% of the body surface area, taking into account the body size any topical products other than the study drug that has been applied to the trunk and limbs will be switched to the study drug and the area of application will be increased.

Changes in patient satisfaction with treatment (TSQM-9) before and after starting delgocitinib ointment.

Changes in skin rash on the whole body and at the site of application of the drug under study. (changes in EASI and mEASI)
Evaluate changes over time in EASI and mEASI. (0 weeks, 8 weeks, and 12 weeks)
Changes in itching at the site of application of the drug under study. (changes in NRS)
Evaluate changes over time in NRS score. (0 weeks, 8 weeks, and 12 weeks)
Degree of local side effects at the site of application of the drug under study.
Evaluate changes over time in the score. (0 weeks, 1-2 weeks, 4 weeks, 8 weeks, and 12 weeks)
Skin condition at the site of application of the drug under study
Evaluate changes over time in scores for the observed site's dryness, texture, firmness, elasticity, and appearance. (0 weeks and 12 weeks)
Change in disease control (change in ADCT)
Evaluate changes over time in ADCT score. (0 weeks, 4 weeks, 8 weeks, and 12 weeks)
Preference for delgocitinib ointment (PPQ)
Evaluate the preference for delgocitinib ointment compared to the pre-switching topical treatment over time.
(12 weeks)

+81-45-682-4114

May. 26, 2023

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