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

JRCT ID: jRCTs031230102

Registered date:29/05/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 14/07/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

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

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Abe Masatoshi
• Secondary Sponsor: Miyachi Yoshiki
• Source(s) of Monetary Support: Torii Pharmaceutical Co., Ltd