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

Primary Purpose

Cutaneous Hypersensitivity

Status

Terminated

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone

About this trial

This is an interventional treatment trial for Cutaneous Hypersensitivity

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

Alergoalpha
Allergisa
Hospital Nipo Brasileiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy of treatment in acute cutaneous rash based on symptoms score

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

Safety will be evaluated by the adverse event occurrences

Adverse events will be recorded and followed in order to evaluate safety and tolerability

Full Information

NCT ID

NCT01529242

First Posted

February 6, 2012

Last Updated

February 15, 2017

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01529242

Brief Title

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

Official Title

A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

By sponsor decision due to difficulty of recruitment

Study Start Date

February 2014 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desloratadine + Prednisolone

Arm Type

Experimental

Arm Description

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

Arm Title

Dexchlorpheniramine + Betamethasone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Desloratadine + Prednisolone

Intervention Description

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

Intervention Name(s)

Dexchlorpheniramine + Betamethasone

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of treatment in acute cutaneous rash based on symptoms score

Description

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 .

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Safety will be evaluated by the adverse event occurrences

Description

Adverse events will be recorded and followed in order to evaluate safety and tolerability

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirceu Solé, MD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alergoalpha

City

São Paulo

State/Province

Country

Brazil

Facility Name

Allergisa

City

Campinas

State/Province

São Paulo

Country

Brazil

Facility Name

Hospital Nipo Brasileiro

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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