Epicutaneous Immunotherapy for Milk Allergy
Phase 2
Active, not recruiting
- Conditions
- Food allergy (milk)Food allergy, milk allergy, anaphylaxisT781
- Registration Number
- JPRN-jRCTs041200024
- Lead Sponsor
- Takase Takafumi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion 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)
Exclusion Criteria
Uncontrolled atopic dermatitis/bronchial asthma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients pass oral food challenge of cumulative amount of milk at 3 ml after epicutaneous immunotherapy
- Secondary Outcome Measures
Name Time Method Frequency of occurrence of adverse events<br>Changes in milk, casein, alpha lactalbumin, beta lactoglobulin specific IgE antibodies, and casein specific IgG4 antibodies<br>Change in the diameter of the wheal in the Prick test<br>Change in threshold values before and after the study treatment<br>Proportion of participants who pass oral food challenge to 3ml of milk at 48 weeks