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Pharmacodynamic Study of JTE-061 Cream - Pharmacodynamic Effects of JTE-061 Cream in Patients with Atopic Dermatitis -

Pharmacodynamic Study of JTE-061 Cream - Pharmacodynamic Effects of JTE-061 Cream in Patients with Atopic Dermatitis -

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No notable findings in AD patients or healthy adults were identified in baseline characteristics (age, sex, SCH, TEWL, etc.).

A total of 30 patients with AD received the investigational product. Of these, 29 patients completed the study. In 10 healthy adults, the reference assessment was performed.

No new safety concerns for treatment with JTE-061 cream were noted in this study.

<Primary endpoints> The SCH of the target affected area was significantly higher at Week 8 than at baseline. The TEWL of the target affected area was significantly lower at Week 8 than at baseline. <Secondary endpoints> The improvement over time in IGA score of target affected area were noted. The mean severity score of the target affected area decreased over time.

When JTE-061 cream 1% was administered once a adaily for 8 weeks to patients with AD, improvements in SCH and TEWL of the target affected area were noted. The study results suggest that treatment with JTE-061 cream improves skin barrier function in patients with AD.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2011210062

Nemoto Takanori

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan

clinicaltrials-info@shionogi.co.jp

clinical trials information

Shionogi & Co.,Ltd.

3-4-1, Nihonbashi-Honcho , Chuo-ku, Tokyo, Japan

+81-3-6635-3505

clinicaltrials-info@shionogi.co.jp

Complete

Mar. 01, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

<Patients with AD>
1. Japanese patients aged >=20 years at informed consent who can visit the study site as an outpatient
2. Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
3. Patients whose Investigator's Global Assessment (IGA) score, affected area, Stratum Corneum Hydration (SCH), and Transepidermal Water Loss (TEWL) of the target affected area meet the criteria specified in the study protocol
<Healthy adults>
1. Healthy Japanese men and women aged >= 20 years at informed consent

<Patients with AD>
1. Patients with a current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
2. Patients with a history of or current acute active bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, and chicken pox) skin infection on the forearm with the target area within 1 week prior to Week 0.
3. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
4. Patients with serious concomitant disease(s)
5. Patients with a history of or current cancer within 5 years prior to screening visit
<Healthy adults>
1. Persons with serious concomitant disease(s)
2. Persons with a skin condition such as eczema, dermatitis, xeroderma, pigmentation disorder, skin inflammation due to sunburn, trauma, or scars on the forearm with the target area that may affect the assessments of the study
3. Persons with a history of or current contact dermatitis, mechanical urticaria, or cutaneous hypersensitivity caused by topical agent or adhesive plasters or tapes, or atopic dermatitis that may affect the assessments of the study
4. Persons who have used a topical agent on the forearm with the target area within 1 week prior to the assessment visit

Both

Atopic Dermatitis

Once daily topical application of thin layer of JTE-061 cream 1% to the target area (the target affected area and target unaffected area) on either left or right volar forearm

- Mean change in SCH of the target affected area from Baseline at Week 8
- Mean change in TEWL of the target affected area from Baseline at Week 8

+81-11-221-8807

Mar. 01, 2022

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