Bioemagno’s Clinical Pharmacology Unit recently completed a rigorous Phase 1 human safety study evaluating Ion Gel ZCM-25®, a Class II medical device developed with advanced Ion Biotechnology Aqueous Ligands (IBAL) technology. This study assessed the gel’s dermal tolerability following repeated high-dose topical administration over a 14-day period in healthy volunteers.
The results were highly encouraging: Ion Gel ZCM-25® was classified as non-irritating, with no adverse dermal reactions reported among research participants. This milestone affirms the gel’s high safety profile, supporting its future clinical and outpatient applications for wound care, infection prevention, and skin recovery therapies.
The clinical trial was conducted under Good Clinical Practice (GCP) standards at Bioemagno’s certified facility, with funding provided by the Mexican government to promote national healthcare innovation.
The primary objective of the study was to determine the tolerability, safety, and dermal response of Ion Gel ZCM-25® under repeated high-dose topical application.
Participants were healthy adult volunteers with no pre-existing skin conditions, ensuring that any dermal effects would be attributable solely to the investigational product. Applications were administered over 14 consecutive days, simulating real-world intensive use scenarios.
Researchers monitored participants closely for signs of irritation, redness (erythema), swelling (edema), allergic reactions, or other dermal adverse events.
Across all participants, Ion Gel ZCM-25® demonstrated excellent dermal tolerability:
Clinical assessments, including dermatological examinations and participant surveys, confirmed the absence of irritation. Based on these findings, Ion Gel ZCM-25® was officially classified as a non-irritant device according to the study’s evaluation protocols.
These human findings reinforce previous preclinical data showing that Ion Gel ZCM-25® is safe and non-irritating, even under extended high-dosage exposure.
Ion Gel ZCM-25® introduces an innovative therapeutic method by delivering bioavailable ions—zinc, copper, magnesium, sulfur, and hydrogen—through an advanced aqueous ligand system.
Unlike traditional topical treatments that rely on antibiotics or steroids, it promotes healing by restoring ionic balance, reducing oxidative stress, and enhancing natural skin regeneration without contributing to antibiotic resistance.
Confirming its dermal safety through human clinical research was crucial to validate this approach. Metal ions, if improperly formulated, can irritate or sensitize the skin.
The positive outcomes reinforce Ion Gel ZCM-25® as a highly biocompatible, next-generation option for wound care.
Following the successful clinical evaluation, Ion Gel ZCM-25® is well-positioned for clinical use in:
Its non-irritant properties make it particularly suited for outpatient care, homecare settings, and for treating sensitive skin in elderly or immunocompromised patients.
The Phase 1 human safety study conducted by Bioemagno’s Clinical Pharmacology Unit provides strong evidence that Ion Gel ZCM-25® is safe, non-irritating, and highly tolerable when used under repeated topical applications over 14 days.
Supported by Mexican government funding and performed under internationally recognized clinical research standards, these findings strengthen Ion Gel ZCM-25®'s positioning as a leading next-generation topical therapeutic for wound healing and infection control.
As healthcare systems worldwide seek non-antibiotic, biocompatible solutions for wound management, Ion Gel ZCM-25® offers a validated, innovative option grounded in rigorous clinical research.