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.
Tolerability to the product was determined, measured the presence of irritability (edema and/or erythema), vital signs were also measured, directed questioning and medical interrogatories were carried out to detect adverse events.
During handling, 3 types of adverse events were identified, distributed in 9 subjects: 4 women and 5 men; 4 subjects had more than one event, in total there were 13 adverse events. No event required pharmacological treatment or motivated the withdrawal of the subject. The results of the measurement of vital signs in the aforementioned follow-up times did not show clinically relevant changes.
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.