Background: Allergic responses to common environmental agents are believed to be involved in the development of atopic dermatitis, but clinical usefulness of allergen-specific immunotherapy in the treatment of atopic dermatitis is controversial. We performed a pilot study to evaluate the clinical usefulness of combined treatment with allergen-specific immunotherapy and a histamine-immunoglobulin complex in patients with atopic dermatitis. Methods: Twenty patients with atopic dermatitis and hypersensitivity to house dust mites whose clinical conditions had not been effectively controlled by current standard medical therapies were treated with a combination of allergen-specific immunotherapy using house dust mite extract and a histamine-immunoglobulin complex for 12 months. The primary efficacy outcome was the change in the standardized clinical severity scoring system for atopic dermatitis (SCORAD) values at 6 and 12 months in comparison with the values at baseline. Results: In 18 patients who completed all 12 months of treatment, the SCORAD values significantly decreased from 43.6 ± 15.9 at baseline to 27.8 ± 18.3 at 6 months and 18.3 ± 14.9 at 12 months (Wilcoxon signed-rank test, p < 0.001), and no significant systemic side effects were observed. Conclusions: In this uncontrolled pilot study, combined treatment with allergen-specific immunotherapy and a histamine-immunoglobulin complex resulted in significant clinical improvements in patients with atopic dermatitis. However, double-blind placebo-controlled studies are necessary to test the clinical usefulness of this modified allergen-specific immunotherapy for atopic dermatitis.

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