Ion Gel ZCM-25® Clinical Phase 2 Human Dosing & Efficacy Study

Ion Gel ZCM-25® Clinical Phase 2 Human Dosing & Efficacy Study with COFEPRIS Approval

The Ion Gel ZCM-25® Clinical Phase 2 Human Dosing and Efficacy Study is a pivotal research effort designed to evaluate the therapeutic performance and tolerability of the topical gel in human subjects. Developed by Bioemagno S.A. de C.V. Clinical Pharmacological Unit, this study was approved by the Ethics and Research Committees and endorsed by COFEPRIS, in line with Good Clinical Practice and the applicable national regulations.

The study, which was initiated in Q4 of 2021 with partial government funding, builds upon the solid foundation of Phase I studies, where Ion Gel ZCM-25® demonstrated high tolerability, no adverse dermal reactions, and positive redox-related antioxidant effects in human and animal models.

Study Design and Objectives

As part of a rigorous clinical phase design, this double-blind, placebo-controlled Phase 2 trial involves multiple test groups to evaluate both dosage tolerability and clinical efficacy. Key measurements include:

• Presence or absence of edema and erythema
• Vital signs and medical monitoring
• Subject-reported quality of life improvements
• Biochemical parameters linked to oxidative stress reduction

These criteria aim to confirm the effectiveness of ION-ZCM1, the active ingredient, in modulating redox mechanisms to support healing and infection control.

Phase I Findings as Foundation

Before advancing to Phase 2, several safety and tolerability studies confirmed that Ion Gel ZCM-25® is a non-irritant, with no systemic toxicity and excellent dermal tolerability in both human and animal models:

• Phase I Study (UNAM & Bioemagno, 2020): 20 healthy subjects completed the protocol with no clinically relevant changes in vital signs.
• Preclinical Rabbit Irritation Study (UNIPREC, 2019): Demonstrated absence of adverse reactions, supporting dose escalation.
• In vitro MTT cytotoxicity assay: Established a favorable safety profile on human skin cell lines (HACAT) at 25% concentration.

Therapeutic Goals of Phase 2

The Phase 2 study evaluates Ion Gel ZCM-25® for potential indications including:

• Accelerated wound healing
• Reduction of microbial burden (viruses, fungi, bacteria)
• Management of inflammatory skin responses
• Support in post-surgical skin recovery

The study will assess the product's ability to penetrate the skin barrier, maintain therapeutic ionic bioavailability, and enhance tissue regeneration by leveraging the redox signaling of Zn²⁺, Cu²⁺, and Mg²⁺ ions.

Regulatory Oversight and Government Support

The clinical phase study received regulatory review and approval by COFEPRIS, aligning with Mexico’s national health policies for innovative medical technologies. Its partial funding by the Mexican Government signals the public health value attributed to Ion Gel ZCM-25® in wound care and infection control frameworks.

Key Highlights from the Study Protocol

• Number of Subjects: 20, with balanced gender distribution
• Application Area: 4 cm² skin patches on the forearm, exposed for 14 days
• Dose: 0.5 mL/day, applied topically under clinical observation
• Safety Monitoring: ECG, medical history, and full consent protocol followed
• Outcome Measures: Tolerability, adverse events, redox biomarker reduction

Learn More

For additional details about Ion Gel ZCM-25® clinical research and safety studies, visit:
https://zcm25.com/resources