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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cutaneous Hypersensitivity
• Intervention / Treatment: Drug: Desloratadine + Prednisolone; Drug: Dexchlorpheniramine + Betamethasone

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Nipo Brasileiro
  • SP
    • São Paulo, SP, Brazil
      • Alergoalpha
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desloratadine + Prednisolone; desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution	Drug: 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
Active Comparator: Dexchlorpheniramine + Betamethasone; dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be evaluated by the adverse event occurrences	Adverse events will be recorded and followed in order to evaluate safety and tolerability	5 days

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Dirceu Solé, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Asthmatic Agents; Respiratory System Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Prednisolone; Betamethasone; Desloratadine; Dexchlorpheniramine
• Other Study ID Numbers: DPUEMS1111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No