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