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

JRCT ID: jRCT2011210062

Registered date:17/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 19/04/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

Primary Outcome

- 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

Key inclusion & exclusion criteria

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

Include criteria

<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

Exclude criteria

<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

Related Information

• Primary Sponsor: Nemoto Takanori
• Source(s) of Monetary Support: Torii Pharmaceutical Co.,LTD