Overview
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
Status:
Terminated
Terminated
Trial end date:
2016-10-20
2016-10-20
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
EMSTreatments:
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Chlorpheniramine
Desloratadine
Dexchlorpheniramine
Loratadine
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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