In short
Polyhexanide solution 20% (SW/DAC) is an antiseptic substance being studied as a topical treatment for chronic wounds colonized by Pseudomonas aeruginosa, a bacterium that can delay healing. One Phase 2 clinical trial is currently authorised, planning to enrol 90 participants. The trial compares the investigational product PB-TX-01 against a marketed antiseptic solution, Serasept® 2, over a 90-day observation period.
Key points
- Phase 2 trial authorised for chronic wounds colonized by Pseudomonas aeruginosa.
- Planned enrolment of 90 participants.
- Compares PB-TX-01 (containing polyhexanide) with Serasept® 2, an antiseptic solution.
- Primary measures include safety (adverse events) and bacterial load reduction after 14 days.
- Participants are followed for 90 days after treatment.
- Trial identifier: 2024-517491-38-00.
What is polyhexanide solution 20% (SW/DAC)?
Polyhexanide solution 20% (SW/DAC) is an antiseptic substance. In the clinical trial record, it appears as the active component of the investigational product PB-TX-01, which is applied directly to wounds. The trial also uses Serasept® 2 Antiseptische Lösung, a marketed antiseptic solution, as the comparator arm. Polyhexanide is a chemical antiseptic used to reduce the number of microorganisms on living tissue. The trial record does not state whether the 20% solution is already authorised as a medicine or remains investigational.
How does polyhexanide solution 20% (SW/DAC) work?
The trial record does not describe the molecular mechanism of action of polyhexanide. As an antiseptic, it is expected to act against microorganisms on the wound surface. The trial measures this effect by counting colony forming units (CFUs) — the number of live bacteria that can grow from a wound swab — after 14 days of topical application. A reduction in CFUs would indicate that the substance has reduced the bacterial load.
Which conditions is polyhexanide solution 20% (SW/DAC) studied for?
The authorised trial studies one condition:
- Chronic wound colonized by Pseudomonas aeruginosa — a long-lasting wound that has become populated by the bacterium Pseudomonas aeruginosa, which can form biofilms and slow down healing.
How is polyhexanide solution 20% (SW/DAC) given?
In the trial, PB-TX-01 is applied topically on the wound at a dose of 2 grams. The comparator, Serasept® 2, is applied as a 10 millilitre solution, also topically on the wound. The route of administration is therefore topical application directly to the affected wound area.
What do the clinical trials show?
One Phase 2 interventional trial is authorised, with a planned enrolment of 90 participants. The trial is designed to evaluate both safety and efficacy. The primary safety measure is the incidence, severity, and causality of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) within 90 days, coded using the MedDRA dictionary and graded according to CTCAE v6.0. The primary efficacy measure is the reduction of P. aeruginosa bacterial load after 14 days of treatment relative to baseline, assessed by categorising CFUs from wound swabs into five levels from "not existent" to "abundant". A reduction is defined as at least one level less. The trial status is Authorised, meaning it has received regulatory approval to proceed but may not yet be recruiting.
What side effects are known?
The trial record does not list known side effects for polyhexanide solution 20% (SW/DAC). The trial itself is designed to collect this information by recording all treatment-emergent adverse events and serious adverse events over a 90-day period.