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

EMS

Status and phase

Terminated

Phase 3

Conditions

Cutaneous Hypersensitivity

Treatments

Drug: Dexchlorpheniramine + Betamethasone

Drug: Desloratadine + Prednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529242

DPUEMS1111

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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