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

Phase 3CompletedNCT01541930

Galderma R&D21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malodorous Infected Cutaneous Ulcer

Interventions

GK567DRUG

Once or twice daily, for 14 days, up to 30 g per day

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

Galderma investigational site

Kanagawa, Japan

Galderma investigational site

Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: at Day 14 (end of treatment)

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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