EASII Study

JRCT ID: jRCTs051240012

Registered date:18/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 05/06/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): The anti-Staphylococcus aureus ostrich antibody emulsion will be put the target lesion over on the left side and placebo emulsion will be put the target lesion over on the right side, per two palms with 0.5g (2cm in diameter) twice daily (morning and evening, after bathing if possible) for 4 weeks.

Outcome(s)

• Primary Outcome: Rates of change from baseline to 4 weeks after started the treatment at Eczema Area and Severity Index (EASI) score in local lesion

Secondary Outcome

Rates of change from baseline to 2 weeks after started the treatment at EASI score in local lesion.
Points of change from baseline to 2 or 4 weeks after started the treatment at Numerical Rating Scale score.
Points of change from baseline to 2 or 4 weeks after started the treatment at The Patient Oriented Eczema Measure score.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with atopic dermatitis receiving therapy with dupilumab for 16 weeks
2) Patients who having treatment-resistant bisymmetric lesion evaluated the same grade severity (four categories: mild, moderate, severe, most severe) with Eczema Area and Severity Index (EASI) score in local lesion
3) Patients who are 18 years old and more at informed consent
4) Patients who is eligible to agree with consent form

• Exclude criteria: 1)Patients determined ineligible to participate by principal investigator or sub investigator

Related Information

• Primary Sponsor: Miyagawa Fumi
• Source(s) of Monetary Support: ZEAL COSMETICS Inc.