A pharmacological study of M1151C2

JRCT ID: jRCT2031210012

Registered date:06/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 12/04/2021
• Target sample size: 30
• Study type: Interventional
• Intervention(s): apply appropriate amount of Tacrolimus ointment 0.1% to the affected areas of the skin once daily

Outcome(s)

• Primary Outcome: usability of the investigational

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Confirmed diagnosis of atopic dermatitis

Exclude criteria

Patients with a history of, or currently with any of the following diseases:
1) malignact tumor
2) Serious allergy (shock, anaphylactoid symptoms)
3) Allergy to tacrolimus
4) Cutaneous hypersensitivity to topical drugs (e.g., allergic contact dermatitis)
Patients with any of the following diseases:
1) Diseases considered inappropriate for study participation, such as serious cardiac, hepatic, renal, pulmonary, or hematologic diseases
2) Severe renal dysfunction, severe hyperkalemia or symptoms caused by them
3) ulcer or erosion clearly forming a plaque at the application site of the investigational drug
4) Diseases with ichthyosis-like erythroderma (Netherton syndrome, etc.)
5) Skin infections at the application site of the investigational

Related Information

• Primary Sponsor: Nishiura Tomoyuki