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

Cutaneous Hypersensitivity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01529242
• Other study ID #: DPUEMS1111
• Status: Terminated
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: February 15, 2017
• Start date: February 2014
• Est. completion date: October 20, 2016

Study information

• Verified date: February 2017
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 20, 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Cutaneous Hypersensitivity
• Dermatitis, Atopic
• Hypersensitivity

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Allergisa	Campinas	São Paulo
Brazil	Alergoalpha	São Paulo	SP
Brazil	Hospital Nipo Brasileiro	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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