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

NCT ID: NCT01529242

Last Updated: 2017-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-10-20

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.

Conditions

Cutaneous Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Desloratadine + Prednisolone

desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution

Group Type: EXPERIMENTAL

Desloratadine + Prednisolone

Intervention Type: 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

Dexchlorpheniramine + Betamethasone

dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution

Group Type: ACTIVE_COMPARATOR

Dexchlorpheniramine + Betamethasone

Intervention Type: 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

Interventions

Desloratadine + Prednisolone

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Intervention Type: DRUG

Dexchlorpheniramine + Betamethasone

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirceu Solé, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Allergisa

Campinas, São Paulo, Brazil

Alergoalpha

São Paulo, São Paulo, Brazil

Hospital Nipo Brasileiro

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DPUEMS1111

Identifier Type: -

Identifier Source: org_study_id