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Efficacy and safety of epicutaneous immunotherapy for severe milk allergy; Long term trial

Efficacy and safety of epicutaneous immunotherapy for severe milk allergy; Long term trial - Epicutaneous immunotherapy for milk allergy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027459
Enrollment
40
Registered
2017-05-29
Start date
2017-05-29
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

s milk concentrate for 12 hours a day for 48 weeks Cutaneous application of hydrogel patch containing cow&#39
s milk concentrate for 12 hours a day for 24 weeks

Sponsors

National Hospital Organization Mie National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Milk allergy diagnosed by oral food challenge (OFC) without tendency of natural outgrow 2) Milk dose threshold of OFC =<3ml(total dose) and underwent cutaneous application of cow's milk concentrate-containing hydrogel patch or hydrogel patch without containing antigen for 24 weeks. 3)Milk dose threshold of OFC =<3ml(total dose) after intervetion of 2).

Exclusion criteria

Exclusion criteria: 1)patients who have heart, liver and kidney diseases 2)patients with ncontrolled asthma or atopic dermatitis

Design outcomes

Primary

MeasureTime frame
Proportion of the subjects who tolerate more than 3 ml of milk (total dose) at oral milk challenge after the treatment for 48 weeks

Secondary

MeasureTime frame
1.Change of dose threshold in oral milk challenge after 24 weeks of treatment 2.Safety:local reaction,systemic immediate-type allergic reaction and other 3.Prick test 4.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