Phase 3
N=21
An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours
Malodorous Infected Cutaneous Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT01541930 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Feb 2014
Primary outcome: Primary: The Success Rate — 95.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GK567 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Success Rate |
95.2 | — |
| SECONDARY Smell Score by Investigator |
0; 11; 13; 0; 5; 6 | — |
| SECONDARY Smell Score by Nurse |
1; 12; 15; 3; 4; 4 | — |
| SECONDARY Smell Score by Patient |
1; 9; 16; 8; 12; 4 | — |
| SECONDARY Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) |
1; 5; 7; 12; 12; 10 | — |
| SECONDARY Pain (Visual Analogue Scale) |
28.3; 25.9; 22.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01541930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.