Atopic dermatitis
Conditions
Interventions
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 tru
Sponsors
Abe Masatoshi
Miyachi Yoshiki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in patient satisfaction with treatment (TSQM-9) before and after starting delgocitinib ointment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Contacts
Public ContactTaguchi Ryoichi
EBC&M LLC
Outcome results
None listed