Epicutaneous Immunotherapy in Peanut Allergy in Children

NCT01197053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-10-20

No results posted yet for this study

Summary

This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.

Conditions

Interventions

BIOLOGICAL

Epicutaneous Immunotherapy

100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm

BIOLOGICAL

placebo of peanut

placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm

Sponsors & Collaborators

  • DBV Technologies

    collaborator INDUSTRY
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe Dupont, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197053 on ClinicalTrials.gov