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

This study aimed to evaluate the tolerability of Ion Gel ZCM-25® as a topical antimicrobial gel. Tolerability was measured by assessing potential irritability, specifically monitoring for edema and/or erythema, over a 14-day application period in healthy subjects.

Methods

Twenty research participants of both sexes were recruited for the study. A dose of 0.5 mL of Ion Gel ZCM-25® was applied daily for 14 days, with evaluations conducted across 15 visits. Data on topical tolerability and skin response were analyzed using Excel tools for Microsoft 365 MSO. The study recorded key variables, including edema and/or erythema, based on clinical evaluations using the FEUM (12th Ed.) irritability scale, a standardized method for assessing skin reactions to topical treatments.

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 was lower than typically observed in irritability tests on healthy skin. According to the FEUM classification, Ion Gel ZCM-25® is classified as non-irritant, supporting its suitability as a gentle antimicrobial gel for topical use.

Conclusions

Ion Gel ZCM-25® demonstrated high tolerability on healthy skin in research subjects following repeated daily applications for 14 days. These findings highlight its potential as a non-irritating topical solution for skin health and antimicrobial applications, making it suitable for broader clinical and healthcare uses.

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