Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis (NCT NCT01536795)
NCT ID: NCT01536795
Last Updated: 2021-02-12
Results Overview
Safety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
During 20 day treatment period
Results posted on
2021-02-12
Participant Flow
48 subjects were randomized and received treatment at the Institut Pasteur de Tunis and primary healthcare centers and schools of the study area in Sidi Bouzid and Elmmara, Tunisia.
Participant milestones
| Measure |
WR279,396 With Tegaderm Dressing
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
WR279,396 With Tegaderm Dressing
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
Baseline characteristics by cohort
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Middle Eastern or North African
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other (European/Arab)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Tunisia
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Subjects with a previous history of leishmaniasis
Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Subjects with a previous history of leishmaniasis
No
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During 20 day treatment periodSafety of WR279,396 through the tracking of local, systemic and spontaneous adverse reactions
Outcome measures
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Safety: Overview of Adverse Events
Withdrawals due to an AE
|
0 Participants
|
0 Participants
|
|
Safety: Overview of Adverse Events
Subjects with atleast 1 AE
|
16 Participants
|
7 Participants
|
|
Safety: Overview of Adverse Events
Subjects with an SAE
|
0 Participants
|
0 Participants
|
|
Safety: Overview of Adverse Events
Not due to an AE
|
0 Participants
|
1 Participants
|
|
Safety: Overview of Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 50, 90Efficacy will be evaluated in terms of the number of lesions cured at D50 (D1 is the first day of treatment) with no relapse by Day 90. Complete clinical respoonse is defined as 100% re-epithelialization of the index lesion by Day 50 or a \> 50% re-epithelialization by Day 50 followed by complete re-epithelialization on or before Day 90, with no relapse ever having occurred from Day 50 through Day 90.
Outcome measures
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 90 - Improved
|
2 Participants
|
2 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 50 - Not Evaluable
|
1 Participants
|
2 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 50 - Cured
|
19 Participants
|
20 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 50 - Improved
|
2 Participants
|
2 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 50 - Failure
|
2 Participants
|
0 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 90 - Not Evaluable
|
1 Participants
|
2 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 90 - Cured/Improved at D50 with no relapse
|
17 Participants
|
20 Participants
|
|
Clinical Responses of Index Lesions (100% Re-epithelialization)
Day 90 - Failure
|
4 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 10, 20, 50 and 90Area of the index lesion's ulceration over time in mm2
Outcome measures
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Area of the Index Lesion's Ulceration by Study Day
Day 0/1
|
127.0 mm^2
Standard Deviation 147.39
|
157.69 mm^2
Standard Deviation 179.52
|
|
Area of the Index Lesion's Ulceration by Study Day
Day 10
|
118.87 mm^2
Standard Deviation 106.41
|
140.64 mm^2
Standard Deviation 157.74
|
|
Area of the Index Lesion's Ulceration by Study Day
Day 20
|
115.62 mm^2
Standard Deviation 101.45
|
153.51 mm^2
Standard Deviation 176.37
|
|
Area of the Index Lesion's Ulceration by Study Day
Day 50
|
20.0 mm^2
Standard Deviation 48.3
|
1.3 mm^2
Standard Deviation 6.2
|
|
Area of the Index Lesion's Ulceration by Study Day
Day 90
|
30.8 mm^2
Standard Deviation 117.9
|
0.00 mm^2
Standard Deviation 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 10, 20, 50 and 90Population: On D50 in the Gauze-Tape group no SD was given in the data table. All good cause efforts to locate the data for Day 50 SD value for gauze and tape dressing arm have been exhausted, data are missing and hence not available to be reported.
Area of the index lesion's induration over time in mm2
Outcome measures
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Area of the Index Lesion's Induration by Study Day
Day 0/1
|
360.7 mm^2
Standard Deviation 262.5
|
505.9 mm^2
Standard Deviation 431.6
|
|
Area of the Index Lesion's Induration by Study Day
Day 10
|
405.14 mm^2
Standard Deviation 250.78
|
495.25 mm^2
Standard Deviation 401.47
|
|
Area of the Index Lesion's Induration by Study Day
Day 20
|
410.15 mm^2
Standard Deviation 269.62
|
468.85 mm^2
Standard Deviation 344.01
|
|
Area of the Index Lesion's Induration by Study Day
Day 50
|
122.7 mm^2
Standard Deviation 249.8
|
148.05 mm^2
Standard Deviation NA
All good cause efforts to locate the data have been exhausted, data are missing and hence not available to be reported.
|
|
Area of the Index Lesion's Induration by Study Day
Day 90
|
74.6 mm^2
Standard Deviation 235.4
|
0.00 mm^2
Standard Deviation 0.00
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 10, 20, 50 and 90Percentage of change of index lesion in induration area from baseline and days 10, 20, 50 and 90
Outcome measures
| Measure |
WR279,396 With Tegaderm Dressing
n=24 Participants
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 Participants
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90
Day 10
|
28.3 % change in induration
Standard Deviation 63.2
|
45.0 % change in induration
Standard Deviation 114.2
|
|
Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90
Day 20
|
30.0 % change in induration
Standard Deviation 62.0
|
51.0 % change in induration
Standard Deviation 116.2
|
|
Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90
Day 50
|
-64.4 % change in induration
Standard Deviation 78.5
|
-83.9 % change in induration
Standard Deviation 30.7
|
|
Percentage Change in Induration Area From Baseline and Days 10, 20, 50 and 90
Day 90
|
-65.1 % change in induration
Standard Deviation 98.5
|
-100.0 % change in induration
Standard Deviation 0
|
Adverse Events
WR279,396 With Tegaderm Dressing
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
WR279,396 With Gauze and Tape Dressing
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WR279,396 With Tegaderm Dressing
n=24 participants at risk
24 patients will be randomly allocated to WR279,396 treatment once-a-day for 20 days with using an occlusive polyurethane Tegaderm dressing
WR279,396 with Tegaderm Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
|
WR279,396 With Gauze and Tape Dressing
n=24 participants at risk
24 subjects will be randomly allocated to WR279,396 treatment once a day for 20 days without an optimized polyurethane dressing (gauze and tape only).
WR 279,396 with Gauze and Tape Dressing: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
2/24 • Number of events 2 • 90 Days
|
0.00%
0/24 • 90 Days
|
|
General disorders
Local reaction (infection at biopsy site)
|
4.2%
1/24 • Number of events 1 • 90 Days
|
0.00%
0/24 • 90 Days
|
|
General disorders
Edema
|
4.2%
1/24 • Number of events 1 • 90 Days
|
20.8%
5/24 • Number of events 5 • 90 Days
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1 • 90 Days
|
16.7%
4/24 • Number of events 4 • 90 Days
|
|
General disorders
Pyrexia
|
0.00%
0/24 • 90 Days
|
4.2%
1/24 • Number of events 1 • 90 Days
|
|
Infections and infestations
Any infection and infestation
|
0.00%
0/24 • 90 Days
|
4.2%
1/24 • Number of events 1 • 90 Days
|
|
Infections and infestations
Erysipelas
|
0.00%
0/24 • 90 Days
|
4.2%
1/24 • Number of events 1 • 90 Days
|
|
Investigations
Any investigations
|
16.7%
4/24 • Number of events 4 • 90 Days
|
4.2%
1/24 • Number of events 1 • 90 Days
|
|
Investigations
Blood creatinine increased
|
16.7%
4/24 • Number of events 4 • 90 Days
|
4.2%
1/24 • Number of events 1 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Blister (vesicles)
|
41.7%
10/24 • Number of events 10 • 90 Days
|
12.5%
3/24 • Number of events 3 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact (allergy to Tegaderm)
|
16.7%
4/24 • Number of events 4 • 90 Days
|
0.00%
0/24 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
29.2%
7/24 • Number of events 7 • 90 Days
|
12.5%
3/24 • Number of events 3 • 90 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place