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

Phase 3

Completed

Conditions: Malodorous Infected Cutaneous Ulcer

Interventions: Drug: GK567

Registration Number: NCT01541930

Lead Sponsor: Galderma R&D

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GK567	GK567	GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g

Primary Outcome Measures

Name	Time	Method
The Success Rate	at Day 14 (end of treatment)	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

Secondary Outcome Measures

Name	Time	Method
Smell Score by Investigator	on Days 0 (baseline), 7, and 14	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
Smell Score by Nurse	on Days 0 (baseline), 7, and 14	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
Smell Score by Patient	on Days 0 (baseline), 7, and 14	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
Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)	on Days 0 (baseline), 7, and 14	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).
Pain (Visual Analogue Scale)	on Days 0 (baseline), 7, and 14	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).