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

Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cutaneous Hypersensitivity

Intervention: Desloratadine + Prednisolone (Drug); Dexchlorpheniramine + Betamethasone (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: EMS

Official(s) and/or principal investigator(s):
Dirceu Solé, MD, Principal Investigator, Affiliation: Federal University of São Paulo

Overall contact:
Joyce Macedo Silva, MD, Phone: +551938879359, Email: pesquisa.clinica@ems.com.br


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

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

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.


Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.


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

Locations and Contacts

Joyce Macedo Silva, MD, Phone: +551938879359, Email: pesquisa.clinica@ems.com.br

Hospital Nipo Brasileiro, São Paulo, Brazil; Recruiting
Flavio Sano, MD
Email: centroestudos@hospitalnipo.org.br

Alergoalpha, São Paulo, SP, Brazil; Recruiting
Luis F Ensina, MD
Email: pesquisa@alergoalpha.com.br

Allergisa, Campinas, São Paulo, Brazil; Recruiting
Andre L Vergnanini, MD, Phone: +55193789-8600
André L Vergnanini, MD, Principal Investigator

Additional Information

Starting date: February 2014
Last updated: July 13, 2015

Page last updated: August 23, 2015

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