Delgocitinib study

Not Applicable

• Conditions: Atopic dermatitis

• Registration Number: JPRN-jRCTs031200160
• Lead Sponsor: Abe Masatoshi

Brief Summary

In atopic dermatitis patients who used CORECTIM Ointment 0.5% for 4 weeks, SCH (lesional and non-lesional sites) and pEASI score improved with statistically significance. It suggested that the treatment improved skin barrier function. Although the TEWL in lesional and non-lesional sites decreased without a statistically significance.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-16
• Study Completion: 2021-02-18
• Results First Posted: 2021-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

(1)Japanese patients diagnosed with atopic dermatitis, prior to informed consent, according to the Definition and diagnostic criteria for atopic dermatitis by the Japanese Dermatological Association
(2)Patients aged >= 20 years when informed consent are obtained and who can be treated on an outpatient basis
(3)Patients who have moderate and/or less moderate atopic dermatitis on whole body at the beginning of the day of observation (Visit 1) and administration (Visit 2)
(4)Patients who have moderate and/or less moderate eruption (pEASI) on the observation area at the beginning of the day of observation (Visit 1) and administration (Visit 2)

(1)Japanese healthy person without atopic dermatitis on the day of visit
(2)Healthy person aged >= 20 years at the time of informed consent

Exclusion Criteria

(1)Patients with active infection on planed administrated area at the beginning of the day of administration (Visit 2)
(2)Patients with ulcer, erosion etc. that obviously forms plaque on planned administrated area at the beginning of the day of administration (Visit 2)
(3)Patients with the following diseases at the beginning of the day of observation (Visit 1) and/or administration (Visit 2)
- Kaposi's varicelliform eruption
- Scabies
- Molluscum contagiousm
- Impetigo contagious
- Psoriasis
- Disorders (Netherton syndrome, etc.) presenting with ichthyosiform erythroderma
- Collagen disease (SLE and dermatomyositis)
- Contact dermatitis
- Skin disorder on the area study drug is to be applied to, which can affect evaluation
(4)Patients who used the Biological products (cytokines, antibody drugs, etc.) within 24 weeks prior to the beginning of the day of administration (Visit 2)
(5)Patients who used the following drug within 28 days prior to the beginning of the day of administration (Visit 2)
- Systemic adrenocortical steroid (oral, injectable, suppository, and inhaled)
- Systemic immunosuppressant
- Live vaccine
(6)Patients who received following therapy within 28 days prior to the beginning of the day of administration (Visit 2)
- phototherapy (UVB, Narrow-band UVB, PUVA, etc.)
- Allergen immunotherapy, desensitization therapy
(7)Patients who applied the topical strongest or very strong steroids on the observation area within 14 days prior to the beginning of the day of administration (Visit 2)
(8)Patients who applied the CORECTIM Ointment 0.5%, Tacrolimus ointment, topical steroids strong and/or less or Moisturizer on the observation area within 7 days prior to the beginning of the day of administration (Visit 2)
(9)Patients with severe complication on brain, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system or mental system, etc.
(10)Patients with a history of severe drug allergies such as anaphylactic shock
(11)Patients with a history of drug addiction or alcoholism
(12)Patients who are pregnant, breastfeeding or may be pregnant (by pregnancy test on the beginning of the day of administration (Visit 2))
(13)Patients with malignant tumor or with a history of malignant tumor within 5 years from the beginning of the day of observation (Visit 1)
(14)Patients who participated in other trials including medical devices or clinical studies with intervention within 12 weeks prior to the beginning of the day of administration (Visit 2)
(15)Patients with a history of side effect of CORECTIM Ointment 0.5%
(16)Patients determined by the investigator to be unsuitable for the study

(1)Healthy person who have other skin diseases such as skin rash on the observation area
(2)Healthy person determined by the investigator to be unsuitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Change in stratum corneum hydration<br>- Change in transepidermal water loss

Secondary Outcome Measures

Name	Time	Method
- pEASI score of the observation area<br>- Skin elasticity of the observation area (R0, R2, R7)<br>- Skin surface condition of the observation area (wrinkles, smoothness, roughness, and dander)<br>- Photography of the observation area<br>- Questionnaire