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

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ClinicalTrials.gov Identifier: NCT01529242
Recruitment Status : Terminated (By sponsor decision due to difficulty of recruitment)
First Posted : February 8, 2012
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
EMS

February 6, 2012
February 8, 2012
February 16, 2017
February 2014
August 2016   (Final data collection date for primary outcome measure)
Efficacy of treatment in acute cutaneous rash based on symptoms score [ Time Frame: 5 days ]

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

Same as current
Complete list of historical versions of study NCT01529242 on ClinicalTrials.gov Archive Site
Safety will be evaluated by the adverse event occurrences [ Time Frame: 5 days ]
Adverse events will be recorded and followed in order to evaluate safety and tolerability
Safety will be evaluated by the adverse event occurrences [ Time Frame: 5 days ]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Not Provided
Not Provided
 
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
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
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.
  • 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cutaneous Hypersensitivity
  • 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
  • Drug: 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
  • Experimental: Desloratadine + Prednisolone
    desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
    Intervention: Drug: Desloratadine + Prednisolone
  • Active Comparator: Dexchlorpheniramine + Betamethasone
    dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution
    Intervention: Drug: Dexchlorpheniramine + Betamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
140
October 20, 2016
August 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01529242
DPUEMS1111
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
EMS
EMS
Not Provided
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
EMS
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP