Efficacy and safety of epicutaneous immunotherapy for severe milk allergy

Efficacy and safety of epicutaneous immunotherapy for severe milk allergy - Epicutaneous immunotherapy for milk allergy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024564

Enrollment

Registered

2016-11-01

Start date

2016-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Food allergy

Interventions

Cutaneous application of hydrogel patch containing cow&#39

s milk concentrate for 12 hours a day for 24 weeks Cutaneous application of simple hydrogel patch for 12 hours a day for 24 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Milk allergy diagnosed by oral food challenge (OFC) without tendency of natural outgrow 2) Mlik dose threshold of OFC =<3ml(total dose)

Exclusion criteria

Exclusion criteria: 1)patients whose intake levels of milk changed within 3 months of the trial 2)patients who had milk oral immunotherapy within 6 months 3) patients who are on other immunotherapy 4)patients who have heart, liver and kidney diseases 5)patients with ncontrolled asthma or atopic dermatitis

Design outcomes

Primary

Measure	Time frame
Proportion of the subjects who tolerate more than 3 ml of milk (total dose) at oral milk challenge after the treatment for 24 weeks	—

Secondary

Measure	Time frame
1.Safety: local reaction, systemic immediate-type allergic reaction and other 2.Prick test 3.Specific IgE and IgG4	—

Countries

Japan

Contacts

Public ContactYu Kuwabara

National Hospital Organization Mie National Hospital Allergy center

yu_surrealist@hotmail.co.jp+81592322531

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026