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Epicutaneous Immunotherapy for Milk Allergy

Randomized Placebo-controlled Multicenter Trial of Epicutaneous Immunotherapy using Casein Hydrolyte Protein-containing Hydrophilic Gel Patch for Children with Sever Milk Allergy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200024
Enrollment
40
Registered
2020-06-26
Start date
2020-12-09
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy (milk) Food allergy, milk allergy, anaphylaxis

Interventions

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
D003888

Sponsors

Takase Takafumi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Uncontrolled atopic dermatitis/bronchial asthma

Design outcomes

Primary

MeasureTime frame
Proportion of patients pass oral food challenge of cumulative amount of milk at 3 ml after epicutaneous immunotherapy

Secondary

MeasureTime frame
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

Contacts

Public ContactTakafumi Takase

National Hospital Organization Mie National Hospital

takatak817@gmail.com+81-59-232-2531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026