NCT01529242

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-08-01
• Completion: 2016-10-20
• First posted: 2012-02-08
• Last updated: 2017-02-16

Locations

3 sites across 1 country: Brazil