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

This study has been terminated.
(By sponsor decision due to difficulty of recruitment)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01529242
First received: February 6, 2012
Last updated: February 15, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Cutaneous Hypersensitivity Drug: Desloratadine + Prednisolone Drug: Dexchlorpheniramine + Betamethasone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 17
Actual Study Start Date: February 2014
Study Completion Date: October 20, 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529242

Locations
Brazil
Alergoalpha
São Paulo, SP, Brazil
Allergisa
Campinas, São Paulo, Brazil
Hospital Nipo Brasileiro
São Paulo, Brazil
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
  More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01529242     History of Changes
Other Study ID Numbers: DPUEMS1111
Study First Received: February 6, 2012
Last Updated: February 15, 2017

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

Additional relevant MeSH terms:
Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Prednisolone acetate
Methylprednisolone acetate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Betamethasone
Betamethasone Valerate
Prednisolone hemisuccinate
Prednisolone phosphate
Betamethasone sodium phosphate
Desloratadine
Loratadine
Dexchlorpheniramine
Chlorpheniramine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017