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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Allergisa
Campinas, São Paulo, Brazil
Alergoalpha
São Paulo, São Paulo, Brazil
Hospital Nipo Brasileiro
São Paulo, São Paulo, Brazil
Efficacy of treatment in acute cutaneous rash based on symptoms score
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 .
Time frame: 5 days
Safety will be evaluated by the adverse event occurrences
Adverse events will be recorded and followed in order to evaluate safety and tolerability
Time frame: 5 days
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