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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Malodorous Infected Cutaneous Ulcer

Intervention / Treatment
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* Drug: GK567


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GK567<br>GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g | Drug: GK567<br>* Once or twice daily, for 14 days, up to 30 g per day<br>* Other names: GK567: Metronidazole Gel 0.75%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Success Rate | The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator | at Day 14 (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smell Score by Investigator | Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell | on Days 0 (baseline), 7, and 14 | 
| Smell Score by Nurse | Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell | on Days 0 (baseline), 7, and 14 | 
| Smell Score by Patient | Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell | on Days 0 (baseline), 7, and 14 | 
| Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody). | on Days 0 (baseline), 7, and 14 | 
| Pain (Visual Analogue Scale) | The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain). | on Days 0 (baseline), 7, and 14 |