atopic dermatitis
Conditions
Interventions
One push (approximately 1.1 g) of the test and control drugs will be applied twice daily (morning and evening) for 4 weeks and spread on the unilateral forearm (from wrist to elbow) on the left and ri
Sponsors
Murota Hiroyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with mild to moderate disease (forearm local IGA score 1-3) diagnosed with atopic dermatitis (AD) based on the criteria of the Japanese Dermatological Association by the time consent is obtained 2) Japanese patients aged 18 years or older at the time of consent (regardless of gender and inpatient or outpatient status) 3) Patients who have started dupilumab treatment for AD and have continued treatment at 2-week intervals for at least 16 weeks at the time of case enrollment. 4) Patients who have been fully informed about the study, fully understand it, and have given written consent of their own free will. 5) Patients who are able to visit the hospital for the number of times and duration specified in the study. 6) Patients who are able to push the pump container with both hands with equal force and apply it properly at the time of obtaining consent.
Exclusion criteria
Exclusion criteria: 1) Patients with significant concomitant skin or inflammatory disease at the time of consent that may affect the evaluation of the study. 2) Patients with a history of acute active bacterial, fungal, or viral skin infection (e.g., Kaposi's varicella-like rash, herpes zoster, erysipelas, cellulitis, scabies) within 1 week at the time of consent 3) Patients who, at the time of consent, have difficulty in equally using topical agents on the right and left forearms due to forearm defects, hemiplegia, etc. 4) Patients with serious complications of the brain, circulatory system, respiratory system, gastrointestinal system, liver, kidney, hematological system, endocrine system, metabolic system, or psychiatric system at the time of consent 5) Patients with known hypersensitivity to any component of the drug or with a history of drug allergy or other allergy that is judged to be contraindicated at the time of obtaining consent. 6) Patients with a difference of 2 or more between the left and right local IGA score of the forearm at the time of case enrollment 7) Patients who have used topical medications or moisturizers on the forearm within 12 hours prior to case enrollment. 8) Patients who used topical steroids, delgocitinib, difamilast, tacrolimus or tapinarof on the forearm within 14 days prior to enrollment. 9) Patients who received very strong or strongest topical steroids on the forearm within 28 days prior to enrollment 10) Patients who received ultraviolet light therapy on the forearm within 16 weeks prior to enrollment 11) All biologics and JAK inhibitors indicated for or potentially effective in AD, including nemolizumab, tralokinumab, lebrikizumab, baricitinib, upadacitinib, and ablocitinib, as well as steroids and oral cyclosporine within 16 weeks prior to case enrollment patients who have received steroids and oral cyclosporine (excluding dupilumab) 12) Other patients deemed inappropriate by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in local EASI score (*total of 4 symptom scores in EASI) on forearm after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage change, amount of change, and measured value of local EASI score of forearm 2 weeks after the start of medication 2. Percentage change in local EASI score of forearm after 4 weeks of medication, amount of change, and actual value 3. Percentage of patients with local IGA score of forearm after 4 weeks of medication 4. Percentage change in local EASI score of forearm 5. Percentage change and amount of change in WI-NRS score of forearm after 4 weeks of medication, measured values 6. Number of days to dropout due to exacerbation of primary disease or adverse events 7. Details and incidence of adverse events and side effects 8. Transcutaneous water transpiration (right and left forearm flexion side: on the first day of treatment, at 4 weeks) 9. Transdermal water transpiration (right and left flexed forearms: on the first day of treatment, at 4 weeks) 10. Bacterial flora analysis 11. Skin fungal flora analysis 12. Qualitative survey | — |
Contacts
Public ContactNaoko Hattori
Nagasaki University Hospital
Outcome results
None listed