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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01529242
Recruitment Status : Terminated (By sponsor decision due to difficulty of recruitment)
First Posted : February 8, 2012
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cutaneous Hypersensitivity Drug: Desloratadine + Prednisolone Drug: Dexchlorpheniramine + Betamethasone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 20, 2016

Arm Intervention/treatment
Experimental: Desloratadine + Prednisolone
desloratadine 0,5 mg/ml + prednisolone 4 mg/ml - oral solution
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

Active Comparator: Dexchlorpheniramine + Betamethasone
dexchlorpheniramine maleate 0,4 mg/ml + Betamethasone 0,05 mg/ml - oral solution
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529242

São Paulo, SP, Brazil
Campinas, São Paulo, Brazil
Hospital Nipo Brasileiro
São Paulo, Brazil
Sponsors and Collaborators
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo

Responsible Party: EMS Identifier: NCT01529242     History of Changes
Other Study ID Numbers: DPUEMS1111
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis, Atopic
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Prednisolone acetate
Methylprednisolone acetate
Betamethasone benzoate
Methylprednisolone Hemisuccinate
Betamethasone Valerate
Prednisolone hemisuccinate
Prednisolone phosphate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs