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
Phase 3
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Malodorous Infected Cutaneous Ulcer
Both
Malodorous Infected Cutaneous Ulcer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The success rate, where success for a patient is defined as a smell score of 0 or 1 as assessed by the Study Investigator
Outcome Time Frame:
at Day 14 (end of treatment)
Safety Issue:
No
Authority:
Japan: MHLW (Ministry of Health, Labour and Welfare)
Study ID:
RDT.07.SPR.27013
NCT ID:
NCT01541930
Start Date:
April 2012
Completion Date:
December 2012
Related Keywords:
- Malodorous Infected Cutaneous Ulcer
- Skin Ulcer
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