NCT01541930

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

An Open, Uncontrolled Study Investigating the Safety and Efficacy of GK567 in the Deodorization of Malodorous Infected Cutaneous Fungating Neoplastic Tumours, Over 14 Days of Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malodorous Infected Cutaneous Ulcer

Interventions

Type	Name	Description
DRUG	GK567	Once or twice daily, for 14 days, up to 30 g per day

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-01
• Last updated: 2014-02-06
• Results posted: 2014-02-06

Locations

2 sites across 1 country: Japan