The phase 4 study of the tacrolimus ointment 0.03% in Infant and toddler patients with Atopic dermatitis

JRCT ID: jRCT2031230181

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic dermatitis
• Date of first enrollment: 23/10/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Apply appropiriate amount of the tacrolimus ointment 0.03% once or twice daily to the affected area

Outcome(s)

• Primary Outcome: EASI

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 2age old
• Gender: Both
• Include criteria: Patients with mild or higher atopic dermatitis aged between 6 months and 2 years.

Exclude criteria

- medical history and/or concomitant disease of malignancy, serious allegies, allegy to tacrolimus or skin hypersensitivity to topical medicinal products.
- serious complication of any cardiac, hepatic, renal, pulmonary, hematological disorder etc, which is considered inappropriate to participate in the trial by investigators.

Related Information

• Primary Sponsor: Nishiura Tomoyuki