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

Cutaneous Hypersensitivity research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cutaneous Hypersensitivity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Desloratadine + PrednisoloneChildren (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 + BetamethasoneChildren (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Terminated

Start Date: February 2014

Completed Date: October 20, 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Efficacy of treatment in acute cutaneous rash based on symptoms score

Secondary Outcome: Safety will be evaluated by the adverse event occurrences

Study sponsors, principal investigator, and references

Principal Investigator: Dirceu Solé, MD

Lead Sponsor: EMS

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01529242

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