An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D
• Treatments: Metronidazole

Criteria

Inclusion Criteria:

• The subject is a male or female aged between 20 years or older.

• The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

Exclusion Criteria:

• The subject is currently receiving systemic antibiotics or received in the last 2 weeks,

• The subject is currently receiving systemic or topical Metronidazole or received in the last week,

• The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,

• The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour