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

Galderma

Status and phase: Completed; Phase 3

Conditions: Malodorous Infected Cutaneous Ulcer

Treatments: Drug: GK567

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541930

RDT.07.SPR.27013

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

GK567

Experimental group

Description:

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

Treatment:

Drug: GK567