Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment

A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.

• double-blind, non-inferiority, prospective, parallel group trial.
• Experiment duration: 05 days.
• 03 visits (day 0, 48 hours and day 5).
• Efficacy will be evaluated for acute cutaneous rash based on symptoms score
• Adverse events evaluation.

Inclusion Criteria:

• Consent of the patient or legal guardian;
• Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
• Children aged between 2 and 11 years and 11 months (up to 30 kg);

Exclusion Criteria:

• Participation in clinical trial in 30 days prior to study entry;
• Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
• Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
• Patients on treatment with monoamine oxidase inhibitors (MAOIs);
• Patients diagnosed with other dermatoses