Background: Subcutaneous allergen-specific immunotherapy is an effective treatment of IgE-mediated allergies, but it requires repeated allergen injections with a risk of systemic allergic reactions. Transcutaneous immunotherapy may improve patient compliance and safety.
Objective: To assess the safety and efficacy of epicutaneous allergen immunotherapy.
Methods: This monocentric, placebo-controlled, double-blind trial was conducted from March 2006 to December 2007 at the University Hospital Zurich. Thirty-seven adult patients with positive skin prick and nasal provocation tests to grass pollen were randomized to receive patches containing either allergen (n = 21) or placebo (n = 16). Treatment took place before and during the pollen season 2006, and follow-up visits took place before (n = 26) and after the pollen season 2007 (n = 30). The primary outcome measures were nasal provocation tests.
Results: Allergen-treated patients showed significantly decreased scores in nasal provocation tests in the first (P < .001) and second year (P = .003) after treatment. In contrast, placebo-treated patients had decreased scores in the first treatment year, 2006 (P = .03), but the effect diminished in the second year (P = .53). Although improvement of nasal provocation test scores was not significantly better in the verum versus placebo group, the overall treatment success was rated significantly higher by the allergen-treated group than by the placebo group (2006, P = .02; 2007, P = .005). No severe adverse events were observed. Occurrence of eczema after allergen patch applications proved stimulation of specific T-cell responses, but was noted as an adverse effect of the treatment.
Conclusion: Epicutaneous allergen immunotherapy is a promising strategy to treat allergies and merits further investigation.