Epicutaneous Immunotherapy for Egg Allergy

JRCT ID: jRCTs031200307

Registered date:18/01/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Egg allergy
• Date of first enrollment: 29/06/2021
• Target sample size: 63
• Study type: Interventional
• Intervention(s): Patients with hen's egg allergy are randomized to receive A: high concentrated ovomucoid-containing hydrophilic gel patch, B: low concentrated ovomucoid-containing hydrophilic gel patch or C: placebo hydrophilic gel patch on the skin 24 hours a day for 24 weeks.

Outcome(s)

• Primary Outcome: Proportion of participants who pass oral food challenge to 150mg of egg protein at 24 weeks

Secondary Outcome

1 Proportion of participants who pass oral food challenge to 500 mg of egg protein at 24 or 48 weeks
2 Proportion of participants who pass oral food challenge to 150 mg of egg protein at 48 weeks
3 Adverse event
4 Changes in immunological markers

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

1 Immediate-type of hen's egg allergy
2 specific IgE to egg white at 3.5 UA/mL or more
3 Participants who have threshold of egg protein cumulative dose of 150mg or less

Exclude criteria

1 Participants with severe symptoms in oral food challenge for hen's egg allergy
2 Participants who have had only gastrointestinal symptoms as allergic symptoms
3 Poorly controlled participants with bronchial asthma and/or atopic dermatitis
4 Participants receiving immunotherapy for other food allergens during this trial

Related Information

• Primary Sponsor: Iwai Fumiko
• Source(s) of Monetary Support: National Hospital Organization,Donation from the participant of the ' We want to bring a new treatment with fewer side effects to children with severe egg allergy ' project (https://readyfor.jp/projects/miehospital2023) which was held in cloud funding service, READY FOR.