Completed

NCT Number: NCT01541930

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

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.

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Key information

Conditions

Malodorous Infected Cutaneous Ulcer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Galderma investigational site, Kanagawa, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GK567

Drug

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

Other names: GK567: Metronidazole Gel 0.75%

Primary outcomes

The Success Rate

Time frame: 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 outcomes

Smell Score by Investigator

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Acronym: GK567

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 1, 2012
Registry last updated: Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.