Malodorous Infected Cutaneous Ulcer Clinical Trial
— GK567Official 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
| Verified date | January 2014 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Galderma investigational site | Kanagawa | |
| Japan | Galderma investigational site | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | at Day 14 (end of treatment) | No |
| Secondary | 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 | on Days 0 (baseline), 7, and 14 | No |
| Secondary | 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 | on Days 0 (baseline), 7, and 14 | No |
| Secondary | 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 | on Days 0 (baseline), 7, and 14 | No |
| Secondary | 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). | on Days 0 (baseline), 7, and 14 | No |
| Secondary | 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). | on Days 0 (baseline), 7, and 14 | No |