In the present Ion Gel ZCM-25® Phase 1 Clinical Study on Humans, the tolerability of the Class II Medical Device, Ion Gel ZCM-25® was evaluated after daily administration for 14 days, the dose of 0.5mL on the intact skin of the left arm of 20 healthy subjects of both sexes, according to the Authorized Research Protocol, NOM-177-SSA1-2013, NOM-012-SSA3-2012 for compliance with Good Clinical Practice and NOM-220-SSA1-2016 in compliance with Pharmacovigilance; as well as in compliance with current sanitary regulations in Mexico.
20 healthy research subjects of both sexes were recruited and included, the test area and the reference area were delimited with a surgical skin marker, the gel was placed in one of the two squares, and allowed to dry according to the protocol and covered. Each day was uncovered, washed, dried, and reapplied the Ion Gel ZCM-25® and the skin was evaluated.
Se determinó la tolerabilidad al producto, se midió la presencia de irritabilidad (edema y/o eritema), también se midieron los signos vitales, se realizaron interrogatorios médicos para detectar eventos adversos.
Durante la manipulación, se identificaron 3 tipos de eventos adversos, distribuidos en 9 sujetos: 4 mujeres y 5 hombres; 4 sujetos tuvieron más de un evento, en total hubo 13 eventos adversos. Ningún evento requirió tratamiento farmacológico o motivó la retirada del sujeto. Los resultados de la medición de los signos vitales en los tiempos de seguimiento mencionados no mostraron cambios clínicamente relevantes.
The results obtained indicate the following: Ion Gel ZCM-25® was well tolerated. The adverse events that occurred were mild and disappeared without pharmacological treatment.