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

Phase 3

Terminated

• Conditions: Cutaneous Hypersensitivity
• Interventions: Drug: Desloratadine + Prednisolone; Drug: Dexchlorpheniramine + Betamethasone

• Registration Number: NCT01529242
• Lead Sponsor: EMS

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.

Study Timeline

• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Study Start: 2014-02
• Primary Completion: 2016-08
• Study Completion: 2016-10-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desloratadine + Prednisolone	Desloratadine + Prednisolone	desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
Dexchlorpheniramine + Betamethasone	Dexchlorpheniramine + Betamethasone	dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution

Primary Outcome Measures

Name	Time	Method
Efficacy of treatment in acute cutaneous rash based on symptoms score	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 Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse event occurrences	5 days	Adverse events will be recorded and followed in order to evaluate safety and tolerability

Trial Locations

Locations (3)

Allergisa; 🇧🇷 Campinas, São Paulo, Brazil

Hospital Nipo Brasileiro; 🇧🇷 São Paulo, Brazil

Alergoalpha; 🇧🇷 São Paulo, SP, Brazil