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.
Full Article - EnglishIon-Gel-ZCM-25-Clinical-1-Publication-PHARMA-Magazine_VOL_2-4-English
Full Article - SpanishIon-Gel-ZCM-25-Clinical-1-Publication-REVISTA_FARMA_VOL_2-4-Spanish