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
Overview
- Phase
- Phase 3
- Intervention
- Dexchlorpheniramine + Betamethasone
- Conditions
- Cutaneous Hypersensitivity
- Sponsor
- EMS
- Enrollment
- 17
- Locations
- 3
- Primary Endpoint
- Efficacy of treatment in acute cutaneous rash based on symptoms score
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
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
* 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Dexchlorpheniramine + Betamethasone
dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution
Intervention: Dexchlorpheniramine + Betamethasone
Desloratadine + Prednisolone
desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
Intervention: Desloratadine + Prednisolone
Outcomes
Primary Outcomes
Efficacy of treatment in acute cutaneous rash based on symptoms score
Time Frame: 5 days
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 .
Secondary Outcomes
- Safety will be evaluated by the adverse event occurrences(5 days)