In the present Phase 1 Clinical Study on humans, the tolerability of the Class II Medical Device, Ion Gel ZCM-25®, was evaluated after daily application for 14 days. A dose of 0.5 mL was applied to the intact skin on the left arm of 20 healthy subjects, both male and female. This study adhered to the Authorized Research Protocol, including NOM-177-SSA1-2013 and NOM-012-SSA3-2012 for compliance with Good Clinical Practice, and NOM-220-SSA1-2016 for compliance with Pharmacovigilance, as well as current sanitary regulations in Mexico.
The 20 participants were recruited and monitored under controlled conditions. The test area and reference area were marked using a surgical skin marker; Ion Gel ZCM-25® was applied to one of the marked areas, allowed to dry, and then covered. Each day, the application site was uncovered, washed, dried, and the gel was reapplied, with the skin evaluated for any signs of irritability or adverse reactions.
Tolerability to the product was assessed by observing for irritability (edema and/or erythema), measuring vital signs, and conducting medical assessments and questionnaires to identify potential adverse events.
During the study, three types of mild adverse events were identified, affecting nine subjects (four women and five men), with four subjects experiencing more than one event, totaling 13 adverse events. None of these events required pharmacological treatment or resulted in participant withdrawal. Vital sign measurements throughout the follow-up periods showed no clinically significant changes.
The results indicate that Ion Gel ZCM-25® was well-tolerated. The mild adverse events observed resolved independently without the need for pharmacological intervention, supporting the gel's safety profile for topical application and its potential as a reliable option for healthcare use.
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