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By sponsor decision due to difficulty of recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine + Prednisolone | Experimental | desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution |
|
| Dexchlorpheniramine + Betamethasone | Active Comparator | dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine + Prednisolone | Drug | Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirceu Solé, MD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa | Campinas | São Paulo | Brazil | |||
| Alergoalpha |
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| Dexchlorpheniramine + Betamethasone | Drug | Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day |
|
| São Paulo |
| São Paulo |
| Brazil |
| Hospital Nipo Brasileiro | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| C121345 | desloratadine |
| D011239 | Prednisolone |
| C018904 | dexchlorpheniramine |
| D001623 | Betamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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