Phase I study to determine the topical tolerability of Ion Gel ZCM-25®.

To evaluate the tolerability of the product Ion Gel ZCM-25®, measured as the degree of irritability: edema and/or erythema, during 14 days of administration in healthy subjects.

Methods. Twenty research subjects of both sexes were recruited, a dose of 0.5 mL of the topical treatment was administered for 14 days and evaluated during 15 visits; all information obtained was processed using Excel tools for Microsoft 365 MSO.

Study variables were recorded: edema and/or erythema as a result of the clinical evaluation during the visits developed during the study. The evaluation scale indicated in the FEUM (12th Ed.) was used.

Results. The incidence of edema and/or erythema, is lower than that presented in the Irritability test in healthy skin, so that, according to the FEUM classification, the product is Non Irritant.

Conclusions. Ion Gel ZCM-25® demonstrated Tolerability in healthy skin of healthy research subjects after repeated administration for 14 days.

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