Delgocitinib study

JRCT ID: jRCTs031200160

Registered date:16/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 18/11/2020
• Target sample size: 33
• Study type: Interventional

Intervention(s)

Subjects apply study drug twice a day for four weeks.
There are evaluations of stratum corneum hydration, transepidermal water loss, pEASI, skin elasticity, skin surface condition, and the photography of the observation area.
There is a questionnaire on the beginning of the day of administration (Visit 2) and four weeks after the administration (Visit 4).

Outcome(s)

Primary Outcome

- Change in stratum corneum hydration
- Change in transepidermal water loss

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

<Patients with atopic dermatitis>
(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
<Healthy person>
(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

Related Information

• Primary Sponsor: Abe Masatoshi
• Secondary Sponsor: Torii Pharmaceutical Co., Ltd.
• Secondary ID(s): N/A