Epicutaneous Immunotherapy for Milk Allergy

JRCT ID: jRCTs041200024

Registered date:26/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Food allergy (milk)
• Date of first enrollment: 09/12/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients with milk allergy are randomized to receive A: hydrolyzed casein-containing hydrophilic gel patch or B: placebo hydrophilic gel patch on the skin 24 hours a day for 24 weeks. If the oral food challenge is positive after 24 weeks, the hydrolyzed casein-containing hydrophilic gel patch group can be administered for another 24 weeks and the placebo hydrophilic gel patch group can be administered for another 48 weeks.

Outcome(s)

• Primary Outcome: Proportion of patients pass oral food challenge of cumulative amount of milk at 3 ml after epicutaneous immunotherapy

Secondary Outcome

Frequency of occurrence of adverse events
Changes in milk, casein, alpha lactalbumin, beta lactoglobulin specific IgE antibodies, and casein specific IgG4 antibodies
Change in the diameter of the wheal in the Prick test
Change in threshold values before and after the study treatment
Proportion of participants who pass oral food challenge to 3ml of milk at 48 weeks

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

1.IgE-mediated milk allergy
2.Immediate allergic symptoms are induced in oral milk challenge by cumulative dose of milk at 3 ml or less
3.Written informed consent by a guardian and informed ascent by a participant(child)

• Exclude criteria: Uncontrolled atopic dermatitis/bronchial asthma

Related Information

• Primary Sponsor: Takase Takafumi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,National Hospital Organization Mie National Hospital