Epicutaneous Immunotherapy in Peanut Allergy in Children
NCT01197053 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2015-10-20
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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