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

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

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Forty-nine patients with atopic dermatitis were screened, and 15 patients who met the eligibility criteria and had the highest TEWL were enrolled. Median[min,max] for age was 41.0[31-52], sex was 9 males and 6 females, and median[min,max] for atopic dermatitis severity (IGA) was 1.0[1.0-2.0]. The history of atopic dermatitis exceeded 5 years in all cases. Five healthy adults were screened and all five who met the eligibility criteria were enrolled. The median [min,max] of age was 48.0 [29.0-54.0], and the gender was 3 males and 2 females.

Registration was conducted only on specific dates to ensure uniformity in the measurement environment, which allowed registration to take place at the pace originally planned.

In this study, there were no reports of deaths, serious disease or the like, non-serious disease or the like, serious adverse events, or non-serious adverse events or other safety information, during the study period, in both atopic dermatitis patients and healthy adults.

In this study, TEWL and SCH (forearm flexion) were evaluated as primary endpoints (at the end of the study) and the following secondary endpoints were evaluated 1. TEWL, SCH (forearm flexion) TEWL, SCH at each time point (at the start of treatment, 2 weeks after treatment, and at the end of the study) and the change from the start of treatment in patients receiving difamilast TEWL, SCH at each time point (at the start of treatment, 2 weeks after treatment, and at the end of the study) and the change from the start of treatment 2. Skin rash evaluation pEASI values on the flexor forearm at the start of treatment and at each time point (2 weeks after treatment and at the end of the study) in patients treated with Difamilast and the percentage improvement from the start of treatment 3. Sebum RNA Sebum RNA expression change and sebum RNA expression The change in TEWL from start to end of the primary endpoint was significantly lower with a mean of -3.73+-2.43 (p<0.001). The mean change in SCH from start to end was 9.32+-4.47 (p<0.001), a significant increase, all of which were favorable.

In this study, we investigated changes in barrier function in patients with atopic dermatitis treated with Difamilast ointment, using TEWL and SCH as indices. The results showed that both TEWL and SCH were favorable not only at the end of treatment but also 2 weeks after the start of treatment. In addition, sebum RNA was also measured to examine the MOA of skin barrier function improvement, and the RNA that showed correlation will be examined in detail in the future

Dec. 31, 2025

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https://jrct.mhlw.go.jp/latest-detail/jRCTs041240111

Numano Kayoko

Ebisu Ray Clinic

Sankei 51 Building 4F, 1-11-2 Ebisu, Shibuya-ku Tokyo

ebisurayclinic@gmail.com

Numao Kayoko

Ebisu Ray Clinic

Sankei 51 Building 4F, 1-11-2 Ebisu, Shibuya-ku Tokyo

+81-3-6277-3917

ebisurayclinic@gmail.com

Complete

Oct. 25, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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

Both

-Patients with atopic dermatitis
-Healthy adults

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.

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)

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

+81-76-218-8346

Aug. 22, 2024

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