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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cutaneous Hypersensitivity

Intervention / Treatment
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* Drug: Desloratadine + Prednisolone
* Drug: Dexchlorpheniramine + Betamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine + Prednisolone<br>desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution | Drug: Desloratadine + Prednisolone<br>* Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day<br>|
| Active Comparator: Dexchlorpheniramine + Betamethasone<br>dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution | Drug: Dexchlorpheniramine + Betamethasone<br>* Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in acute cutaneous rash based on symptoms score | The differences in the intensity of signs and symptoms of acute cutaneous rash between the beginning and end of the study will be used as the primary endpoint of clinical efficacy . | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse event occurrences | Adverse events will be recorded and followed in order to evaluate safety and tolerability | 5 days |