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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01529242

Enrollment

Registered

2012-02-08

Start date

2014-02-28

Completion date

2016-10-20

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Hypersensitivity

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.

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.

Interventions

DRUGDesloratadine + 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

DRUGDexchlorpheniramine + 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of treatment in acute cutaneous rash based on symptoms score	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

Measure	Time frame	Description
Safety will be evaluated by the adverse event occurrences	5 days	Adverse events will be recorded and followed in order to evaluate safety and tolerability

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026