Category: Safety Studies

Preclinical Study PK & Oxidative Stress Reduction

November 18, 2023
In a preclinical study completed in November 2023, led by Dr. José Trinidad Pérez Urizar, Ph.D., a professor in the Biomedical Sciences Department of the University of San Luis Potosí, the objective was to assess the systemic bioavailability of the metal ions—Magnesium (Mg+2), Zinc (Zn+2), and Copper (Cu+2)—contained in the active ingredient ION-ZCM1 (solution) and […]

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

April 27, 2023
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® Phase 1 Clinical Study on Humans

October 5, 2020
In the present study, 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.

Ion Gel ZCM-25® Dosing Comparison Chart

July 24, 2020
Ion Gel ZCM-25® dosing comparison chart across several human and animal dosing studies.

Dermal Irritability Single High Dose Study of Ion Gel ZCM-25® on New Zealand Male Rabbits

August 13, 2019
Abstract   Study Title Dermal Irritability Single High Dose Study of Ion Gel ZCM-25® on New Zealand Male Rabbits Author UNAM - Preclinical Research Unit - UNIPREC - Dr. Azucena Ibeth Carballo Villalobos (Principal Investigator) (2019). Methods A dermal irritation study of the product Ion Gel ZCM-25® as a single dose 0.5 ml over an […]

Dermal Irritability 3 Day Dosing Study of Ion Gel ZCM-25® on New Zealand Male Rabbits.

July 19, 2018
Abstract   Study Title Dermal Irritability 3 Day Dosing Study of Ion Gel ZCM-25® on New Zealand Male Rabbits. Author Center of Investigation and Assistance in Technology and Design of the State of Jalisco A.C, - CIATEJ. Dr. en C. Eduardo Padilla Camberos (2018). Methods A dermal irritation study of the product Ion Gel ZCM-25® […]

In vitro Toxicity Study of ION-ZCM1 on Human Cells Using an MTT Cytotoxicity Test Method

June 26, 2018
Abstract   Study Title In vitro Toxicity Study of ION-ZCM1 on Human Cells Using an MTT Cytotoxicity Test Method Author INDEVION Biotechnology Research and Development Ltd. Principal Investigator Dr. Zsolt Keresztessy, Ph.D. (2018). Methods The data generated from the in vitro cytotoxicity assays were used to predict toxicity under cell culture conditions, based on the […]
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