An exploratory clinical trial to investigate the effect of Difamilast on skin barrier function in patients with atopic dermatitis

JRCT ID: jRCTs041240111

Registered date:24/10/2024

Basic Information

• Recruitment status: Recruiting

Health condition(s) or Problem(s) studied

-Patients with atopic dermatitis
-Healthy adults

• Date of first enrollment: 12/11/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): After informed consent, the amount of application for patients with atopic dermatitis patients is approximately 1 g per 0.1 m2 of the area of skin eruption.

Outcome(s)

Primary Outcome

TEWL and SCH (forearm flexor)
Amounts of change in TEWL and SCH from the start of treatment in patients treated with difamilast (at the end of the research)

Secondary Outcome

TEWL and SCH (forearm flexor)
TEWL and SCH levels at each time point (at the start of treatment, at Week 2 of treatment, at the end of the research) and the amounts of change from the start of treatment

Skin eruption assessment
pEASI score at the forearm flexor at the start of treatment and at each time point (at Week 2 of treatment, at the end of the research) and percent improvement from the start of treatment in patients treated with difamilast

Sebum RNA
Sebum RNA expression changes and sebum RNA expression levels with the use of difamilast ointment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

Patients with atopic dermatitis
Patients who meet all of the following criteria will be included.
1) Patients who have given written informed consent to participation in this research
2) Patients who are aged 18 years or older and 65 years old or younger at the time of informed consent and able to make outpatient visits
3) Patients diagnosed with atopic dermatitis according to the diagnostic criteria of the Japanese Dermatological Association
4) Patients in whom the severity (Investigator's Global Assessment [IGA]) of systemic skin eruption is <= 3 at the start of screening and at the start of treatment
5) Patients with a TEWL level of >= 10 g/h/m2 at the forearm flexor at the start of screening and at the start of administration

Healthy adults
Persons who meet all of the following criteria will be included.
1) Persons who have given written informed consent to participation in this research
2) Healthy persons (males and females) who are aged between 18 and 65 years (inclusive) at the time of informed consent
3) Persons without a history of atopic dermatitis
4.Persons who have not applied topical agents on the face

Exclude criteria

Patients with atopic dermatitis
Patients who meet any of the following criteria will be excluded from the research.
1) Patients complicated with an active infection that may affect this research at the start of treatment
2) Patients in whom the severity (pEASI) of skin eruption is >= 9 points both on the assessment area and the face at the start of screening and at the start of treatment
3) Patients who have an ulcer or an erosion clearly forming plaque on the assessment area and the face at the start of treatment
4) Patients who have an injury or a complication on the assessment area or the face that may affect this research at the start of treatment
5) Patients who were affected by herpes simplex type 1 (herpes labialis, facial herpes)
6) Patients who have received a biological product, an oral JAK inhibitor, a systemic corticosteroid, or a systemic immunosuppressant within 26 weeks before the start of treatment
7) Patients who have received phototherapy (UVB, narrow-band UVB, PUVA, etc.) within 4 weeks before the start of treatment
8) Patients who have used a strongest or very strong topical steroid on the assessment area and the face within 14 days before the start of treatment according to the Japanese guidelines for atopic dermatitis
9) Patients who have used difamilast ointment, delgocitinib ointment, tacrolimus ointment, a strong or weaker topical steroid, or a moisturizer on the assessment area and the face within 7 days before the start of treatment
10) Patients with a serious complication in the brain, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system, psychiatric system, etc.
11) Patients with other diseases considered to affect the safety or evaluation of subjects by the principal investigator or subinvestigator
12) Persons who are pregnant or may possibly be pregnant and persons who are lactating

Healthy adults
Persons who meet any of the following criteria will be excluded from the research.
1) Persons with a skin disease on the face
2) Persons with a predisposing factor for atopic dermatitis such as pollinosis
3) Patients with other diseases considered to affect the safety or evaluation of subjects by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Numano Kayoko
• Source(s) of Monetary Support: Otsuka Pharmaceutical Co.,Ltd