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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by EMS
Information provided by (Responsible Party):
EMS Identifier:
First received: February 6, 2012
Last updated: July 13, 2015
Last verified: July 2015
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    Adverse events will be recorded and followed in order to evaluate safety and tolerability

Estimated Enrollment: 140
Study Start Date: February 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 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.

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
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
  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 identifier: NCT01529242

Contact: Joyce Macedo Silva, MD +551938879359

Alergoalpha Recruiting
São Paulo, SP, Brazil
Contact: Luis F Ensina, MD         
Allergisa Recruiting
Campinas, São Paulo, Brazil
Contact: Andre L Vergnanini, MD    +55193789-8600      
Principal Investigator: André L Vergnanini, MD         
Hospital Nipo Brasileiro Recruiting
São Paulo, Brazil
Contact: Flavio Sano, MD         
Sponsors and Collaborators
Principal Investigator: Dirceu Solé, MD Federal University of São Paulo
  More Information

Responsible Party: EMS Identifier: NCT01529242     History of Changes
Other Study ID Numbers: DPUEMS1111 
Study First Received: February 6, 2012
Last Updated: July 13, 2015
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Betamethasone Valerate
Betamethasone benzoate
Betamethasone sodium phosphate
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal processed this record on May 26, 2016