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

• Status: Terminated
• Trial end date: 2016-10-20
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: 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