Banca de QUALIFICAÇÃO: FABIANNY TORRES DE OLIVEIRA SANTOS

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : FABIANNY TORRES DE OLIVEIRA SANTOS
DATE: 15/07/2022
TIME: 09:00
LOCAL: Sala 221
TITLE:

DERMAL TOLERABILITY AND SYSTEMIC TOXICITY OF GEL FOR TOPICAL USE: A RANDOMIZED CLINICAL TRIAL

KEY WORDS:

Acetic acid; Toxicity; Drug-Related Side Effects and Adverse Reactions; Phase I Clinical Trial.

PAGES: 91
BIG AREA: Ciências da Saúde
AREA: Enfermagem
SUMMARY:

The cutaneous administration of drugs has the objective of topical or systemic action of a substance. However, topical medications can trigger local and/or systemic reactions, as they are absorbed and passed into the bloodstream. Coverages used for the treatment of injuries favor healing and may have antimicrobial action due to the active ingredient. Nevertheless, acetic acid presents promising antimicrobial and antibiofilm results against pathogens, however, there is a gap regarding possible toxic reactions in humans in its use. To assess the safety in the use of acetic acid in humans, from the perspective of the development of biotechnology for the treatment of wounds, we sought to answer the question: Does the gel composed of acetic acid present local tolerance and systemic safety for topical use on intact skin? The objective was to evaluate the local tolerance and systemic toxicity for topical use of the gel composed of acetic acid. This is a phase I randomized clinical trial, three-arm, parallel, double-blind, where 65 healthy participants, of both sexes and over 18 years of age, underwent the repeated open application test (ROAT) with a gel based on 1% acetic acid, 2% (intervention groups) or placebo (control group). There was allocation in the groups through block randomization with a 1:1:1 ratio. A blood sample was collected before and after use of the product and laboratory tests were performed (blood count, TGO, TGP, Gamma GT, urea and creatinine). Made topical use of the product 2x a day for 7 consecutive days, according to ROAT. There was no statistically significant difference in terms of sociodemographic and clinical characteristics between the groups, which differed only in terms of the product used for the intervention. Participants had NEGATIVE ROAT (-) and reported no clinical complaint in the test area; there was no statistically significant difference in laboratory serum values between the groups after exposure to the product; and the laboratory values of the participants remained within the normal range. Therefore, the application of the gel on intact skin was well tolerated, low toxicity of the product is suggested and it is indicated that this formulation, in the dosage and access route tested, can be used by the population, being necessary, still, the development of tests phase II clinical trials to confirm the clinical efficacy of the product in patients with lesions.

BANKING MEMBERS:
Externa ao Programa - 2422344 - PATRICIA DE ALBUQUERQUE SARMENTO
Interna - 1490861 - ROSSANA TEOTONIO DE FARIAS MOREIRA
Presidente - 2582344 - THAIS HONORIO LINS BERNARDO