Dermal Safety Study of JTE-052

JRCT ID: jRCT2031230570

Registered date:16/01/2024

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: atopic dermatitis
• Date of first enrollment: 19/02/2024
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Single application of JTE-052 0.5%

Outcome(s)

• Primary Outcome: Potential for skin irritation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1.Healthy Japanese males aged from 20 to 45 years
2.Those with a body mass index (BMI) of 18.5 to less than 25.0

Exclude criteria

1.Those who have skin conditions that may affect the evaluation in the study, e.g., eczema, dermatitis, pigmentation abnormality, inflammation caused by sunburn, injury, scar, and excessive hair growth, at the prospective application site
2.Those who have a history of contact dermatitis caused by dermatological drugs, adhesive plaster, tape, etc. mechanical urticaria, dermal hypersensitivity, or atopic dermatitis
3.Those to whom JTE-052 has been administered in the past
4.Those for whom the investigator judged it problematic to participate in the study

Related Information

• Primary Sponsor: Koretomo Ryosuke
• Source(s) of Monetary Support: Torii Pharmaceutical Co.,Ltd