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

NCT01529242 | Terminated Phase 3 DMC

• 1 other identifier: DPUEMS1111
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

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.

Conditions

Cutaneous Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety will be evaluated by the adverse event occurrences

  5 days

Study Arms (2)

Desloratadine + Prednisolone

EXPERIMENTAL

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

Drug: Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone

ACTIVE COMPARATOR

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

Drug: Dexchlorpheniramine + Betamethasone

Interventions

Desloratadine + Prednisolone DRUG

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

Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone DRUG

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

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• EMS: lead

Study Sites (3)

Allergisa

Campinas, São Paulo, Brazil

Location

Alergoalpha

São Paulo, São Paulo, Brazil

Location

Hospital Nipo Brasileiro

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

desloratadine; Prednisolone; dexchlorpheniramine; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Dirceu Solé, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 20, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

BR (3)