ocal and systemic reaction of antimicrobial gel: a randomized clinical trial

Phase 1

Recruiting

• Conditions: Drug-Related Side Effects and Adverse Reactions; SP4.046.457.773

• Registration Number: RBR-6srzwwm
• Lead Sponsor: Programa de Pós Graduação em Enfermagem da Universidade Federal de Alagoas

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Study Completion: 2022-07-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: The antimicrobial gel has dermal tolerability.<br><br>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.<br>;Expected outcome 2: The antimicrobial gel is safe for topical use and does not have systemic toxicity.<br><br>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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1: subclinical symptoms identified in the Repeated open application test (ROAT) area.<br><br>Subclinical symptoms will be considered discomfort sensations, which are common reactions and can signal an irritation, characterized by: burning, itching, pain, etc.