Patients were randomized to receive antihistamine drug (5 mg oral desloratadine) or a combined therapy with 5 mg oral desloratadine and 10 mg cysteinyl leukotriene receptor antagonist, montelukast. Randomization was stratified according to disease severity (IGA 3 versus 4) [31 (link)] and affected skin region.
The 5 mg of desloratadine was administered to patients in group I. Patients in group II received a combined therapy with 5 mg of the antihistamine agent and 10 mg of montelukast to match the loading AH dose in Group I. o maintain blinding, coded kits containing desloratadine or combined agents were used to mask treatment assignment. Concomitant topical therapy of AD included application of a topical corticosteroid Elocon (Organon Pharma, UK) twice daily, with 12 h’ interval (morning and evening applications). In both groups, the topical corticosteroid was used with 1-month duration. Twice daily, in the period between the steroid applications a special moisturizer, Topicrem DA (La Roche) was used topically. Additionally, patients of both groups were administered thrice per day with a probiotic, Lacto G (GM Pharmaceuticals) for 4 weeks. The clinical parameters were evaluated in all groups before and after the treatment using different therapy outcomes. The treatment outcomes were assessed after a 12-week therapy period.