Malodorous Infected Cutaneous Ulcer
Conditions
Brief 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.
Interventions
DRUGGK567
Once or twice daily, for 14 days, up to 30 g per day
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Success Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Smell Score by Investigator | 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 | 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 | 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) | 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) | 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). |
Countries
Japan
Participant flow
Recruitment details
April 2012 to December 2012 in Japan
Participants by arm
| Arm | Count |
|---|---|
| GK567 Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | GK567 |
|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 12.2 |
| Primary Disease Breast Cancer | 21 participants |
| Primary Disease Other Cancer | 0 participants |
| Region of Enrollment Japan | 21 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
| Skin Ulcer Size | 68.6 cm^2 STANDARD_DEVIATION 35.4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 21 |
| serious Total, serious adverse events | 1 / 21 |
Outcome results
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
Time frame: at Day 14 (end of treatment)
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GK567 | The Success Rate | 95.2 percentage of participants |
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).
Time frame: on Days 0 (baseline), 7, and 14
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK567 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 0 None | 1 participants |
| GK567 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 1 Mild | 12 participants |
| GK567 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 2 Moderate | 3 participants |
| GK567 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 3 Marked | 5 participants |
| GK567, Day 7 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 3 Marked | 4 participants |
| GK567, Day 7 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 0 None | 5 participants |
| GK567, Day 7 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 2 Moderate | 0 participants |
| GK567, Day 7 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 1 Mild | 12 participants |
| GK567, Day 14 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 3 Marked | 2 participants |
| GK567, Day 14 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 1 Mild | 10 participants |
| GK567, Day 14 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 2 Moderate | 1 participants |
| GK567, Day 14 | Appearance (Volume and Nature of Discharge at Cutaneous Ulcer) | 0 None | 7 participants |
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).
Time frame: on Days 0 (baseline), 7, and 14
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GK567 | Pain (Visual Analogue Scale) | 28.3 mm | Standard Deviation 29.1 |
| GK567, Day 7 | Pain (Visual Analogue Scale) | 25.9 mm | Standard Deviation 27.1 |
| GK567, Day 14 | Pain (Visual Analogue Scale) | 22.2 mm | Standard Deviation 25.3 |
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
Time frame: on Days 0 (baseline), 7, and 14
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK567 | Smell Score by Investigator | 3: Moderately offensive smell | 3 participants |
| GK567 | Smell Score by Investigator | 2: Mildly offensive smell | 13 participants |
| GK567 | Smell Score by Investigator | 0: No smell | 0 participants |
| GK567 | Smell Score by Investigator | 1: Smell present but not offensive | 0 participants |
| GK567 | Smell Score by Investigator | 4: Extremely offensive smell | 5 participants |
| GK567, Day 7 | Smell Score by Investigator | 2: Mildly offensive smell | 2 participants |
| GK567, Day 7 | Smell Score by Investigator | 0: No smell | 11 participants |
| GK567, Day 7 | Smell Score by Investigator | 1: Smell present but not offensive | 5 participants |
| GK567, Day 7 | Smell Score by Investigator | 3: Moderately offensive smell | 3 participants |
| GK567, Day 7 | Smell Score by Investigator | 4: Extremely offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Investigator | 4: Extremely offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Investigator | 3: Moderately offensive smell | 1 participants |
| GK567, Day 14 | Smell Score by Investigator | 0: No smell | 13 participants |
| GK567, Day 14 | Smell Score by Investigator | 2: Mildly offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Investigator | 1: Smell present but not offensive | 6 participants |
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
Time frame: on Days 0 (baseline), 7, and 14
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK567 | Smell Score by Nurse | 3: Moderately offensive smell | 3 participants |
| GK567 | Smell Score by Nurse | 4: Extremely offensive smell | 5 participants |
| GK567 | Smell Score by Nurse | 1: Smell present but not offensive | 3 participants |
| GK567 | Smell Score by Nurse | 0: No smell | 1 participants |
| GK567 | Smell Score by Nurse | 2: Mildly offensive smell | 9 participants |
| GK567, Day 7 | Smell Score by Nurse | 4: Extremely offensive smell | 1 participants |
| GK567, Day 7 | Smell Score by Nurse | 2: Mildly offensive smell | 2 participants |
| GK567, Day 7 | Smell Score by Nurse | 3: Moderately offensive smell | 2 participants |
| GK567, Day 7 | Smell Score by Nurse | 0: No smell | 12 participants |
| GK567, Day 7 | Smell Score by Nurse | 1: Smell present but not offensive | 4 participants |
| GK567, Day 14 | Smell Score by Nurse | 4: Extremely offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Nurse | 0: No smell | 15 participants |
| GK567, Day 14 | Smell Score by Nurse | 1: Smell present but not offensive | 4 participants |
| GK567, Day 14 | Smell Score by Nurse | 2: Mildly offensive smell | 1 participants |
| GK567, Day 14 | Smell Score by Nurse | 3: Moderately offensive smell | 0 participants |
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
Time frame: on Days 0 (baseline), 7, and 14
Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GK567 | Smell Score by Patient | 3: Moderately offensive smell | 4 participants |
| GK567 | Smell Score by Patient | 2: Mildly offensive smell | 6 participants |
| GK567 | Smell Score by Patient | 0: No smell | 1 participants |
| GK567 | Smell Score by Patient | 4: Extremely offensive smell | 2 participants |
| GK567 | Smell Score by Patient | 1: Smell present but not offensive | 8 participants |
| GK567, Day 7 | Smell Score by Patient | 1: Smell present but not offensive | 12 participants |
| GK567, Day 7 | Smell Score by Patient | 0: No smell | 9 participants |
| GK567, Day 7 | Smell Score by Patient | 2: Mildly offensive smell | 0 participants |
| GK567, Day 7 | Smell Score by Patient | 3: Moderately offensive smell | 0 participants |
| GK567, Day 7 | Smell Score by Patient | 4: Extremely offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Patient | 4: Extremely offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Patient | 3: Moderately offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Patient | 0: No smell | 16 participants |
| GK567, Day 14 | Smell Score by Patient | 2: Mildly offensive smell | 0 participants |
| GK567, Day 14 | Smell Score by Patient | 1: Smell present but not offensive | 4 participants |