Drug-Related Side Effects and Adverse Reactions
Conditions
Interventions
110 participants. Experimental group: 4 groups, with 22 healthy participants each, will perform the repeated open application test (ROAT) using antimicrobial gel at different concentrations, depending
gently rub the substance to be tested with the skin
perform the first reading 15 minutes after the first application and the second reading after an hour, the others must be performed daily. If the test is negative, after the first two readings, contin
Sponsors
Programa de Pós Graduação em Enfermagem da Universidade Federal de Alagoas
Unidade Docente Assistencial Prof. Gilberto de Macedo (UDA/UFAL)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Older than 18 years; Faculty and students from the Nursing Undergraduate Course at the Nursing School of the Federal University of Alagoas; User population of the health unit where the research will be carried out; People willing to attend daily follow-up appointments during monitoring.
Exclusion criteria
Exclusion criteria: Presence of any change in the baseline results of laboratory tests; Previous skin alteration at the right or left forearms; Declarants of any underlying pathology, requiring daily or regular use of medication; Reporters of dermal hypersensitivity; Possessors of cognitive alterations; Pregnant women; Alcoholics.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: subclinical symptoms identified in the Repeated open application test (ROAT) area. Subclinical symptoms will be considered discomfort sensations, which are common reactions and can signal an irritation, characterized by: burning, itching, pain, etc. | — |
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: The antimicrobial gel has dermal tolerability. It will be considered with dermal tolerability the gel that presents Repeated open application test (ROAT) with result “NEGATIVE” (-), after reading based on the scale recommended by the European Society of Contact Dermatitis during the follow-up period (7 days). It will be considered that the gel with the result of “POSITIVE” (+) ROAT does not present dermal tolerability for topical use on intact skin. ;Expected outcome 2: The antimicrobial gel is safe for topical use and does not have systemic toxicity. It will be considered without systemic toxicity and therefore safe for topical application to intact skin the gel whose individuals tested do not show changes in any of the laboratory parameters for hematotoxicity (blood count), hepatotoxicity (TGO, TGP and Gamma GT) and nephrotoxicity (urea and creatinine ). The cutoff values established by the clinical analysis laboratory will be adopted as a reference. | — |
Countries
Brazil
Contacts
Public ContactThaís;Fabianny Honório Lins Bernardo;Torres de Oliveira
;
Outcome results
None listed