Conditions: Malodorous Infected Cutaneous Ulcer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment.

The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.

Detailed description:

Arms:
arm 1: GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g

Interventions: intervention 1: GK567
Intervention descriptions: intervention 1: Once or twice daily, for 14 days, up to 30 g per day

Protocol document: