The Human Clinical Studies conducted on Ion Gel ZCM-25® represent a foundational step in its journey from medical device to pharmaceutical drug candidate. Developed by Ion Biotechnology México, this topical formulation is based on IBAL (Ion Biotechnology Aqueous Ligands) technology—a scientifically innovative complex combining zinc, copper, magnesium, sulfur, and hydrogen ions in a hexaqua ligand matrix.
The first formal study, a Phase 1 Clinical Safety Trial, was designed to evaluate tolerability, local skin response, and potential dermal toxicity of the gel applied directly to human skin. This study was approved by an ethics committee in 2019, and its implementation was funded by the Mexican Federation as part of a public–private initiative to support biotech research.
Participants in this study underwent a controlled patch application of Ion Gel ZCM-25® over several weeks. Dermatological evaluations and clinical monitoring were conducted under medical supervision. The outcomes confirmed that the topical application was non-irritating, with no adverse systemic reactions, validating the excellent safety profile previously observed in preclinical toxicology and dermal irritability studies on animal models.
In 2020, the study was formally completed and submitted as part of the regulatory dossier for Ion Gel ZCM-25®. This submission marks a critical advancement in the product's trajectory toward drug classification, especially for indications involving chronic wounds, post-surgical recovery, and infectious skin lesions.
After clearing the first phase of safety testing, the project progressed to Phase 2: a Human Efficacy Study. The goal here is to determine the clinical effectiveness of Ion Gel ZCM-25® in accelerating wound healing and preventing infections, particularly in post-surgical scenarios. Again, this project received funding support from the Mexican Federation and completed its study design and ethics review in 2020.
The study groups were randomized as follows:
The primary endpoints include:
This Human Clinical Study employs a double-blind protocol, ensuring unbiased results that will be central to supporting efficacy claims for regulatory approval. Preliminary data from internal reports suggest that Group 2 (25%) demonstrated a statistically significant improvement in healing time, as well as a lower rate of infection recurrence, compared to both the 10% and placebo groups.
These findings align with in vitro antimicrobial efficacy studies, where Ion Gel ZCM-25® achieved:
The product’s antimicrobial and regenerative properties are supported by its ability to reduce oxidative stress markers by 50% within one day, as shown in oxidative stress reduction studies from the University of San Luis Potosí.
The success of these Human Clinical Studies positions Ion Gel ZCM-25® not only as a next-generation wound care product, but also as a potential pharmaceutical intervention for specialized therapeutic areas, including:
Additionally, these trials reinforce the value of the IBAL delivery system, which enhances bioavailability through a low molecular weight, cationic transport mechanism that penetrates skin layers efficiently while remaining biocompatible.
The outcomes of the Phase 2 efficacy study, once published and peer-reviewed, are expected to support broader regulatory submissions, not just in Mexico (COFEPRIS), but also in international markets looking for innovative topical antimicrobials with clinical validation.
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