ImpetiGO

impetiGO cream

Hydrogen peroxide is a well-established antiseptic used for the topical treatment of superficial bacterial skin infections such as impetigo. In several EU Member States, including the Netherlands, antimicrobial resistance to current first-line topical antibiotic therapies (e.g., fusidic acid) has increased markedly, limiting their clinical effectiveness. This situation represents a public health concern, as resistance trends reduce the availability of effective topical treatments for common community-acquired skin infections.

The proposed product, Hydrogen Peroxide 1% w/w Cream, represents a non-antibiotic therapeutic alternative with a broad antimicrobial spectrum and a low risk for resistance development due to its oxidative mechanism of action. The formulation uses lipid stabilisation technology, enhancing stability and controlled release, supporting consistent antimicrobial activity at the application site.

Given the public health relevance, the increasing antimicrobial resistance to existing first-line options, and the potential for this product to contribute to improved management of superficial skin infections across the EU, it is essential the cream will be registered as a medical product and made available in the EU as an over-the-counter medicine.

Development

Registration EMA

Over-the-counter