Trial Outcomes & Findings for Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia) (NCT NCT00606580)
NCT ID: NCT00606580
Last Updated: 2014-07-14
Results Overview
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows: * Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation. * Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98. * Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168. * Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
Day 42, 98, and 168
Results posted on
2014-07-14
Participant Flow
Participant milestones
| Measure |
WR 279,396 Topical Treament
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
125
|
|
Overall Study
COMPLETED
|
123
|
122
|
103
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
22
|
Reasons for withdrawal
| Measure |
WR 279,396 Topical Treament
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
4
|
|
Overall Study
Clinical failures
|
1
|
0
|
12
|
|
Overall Study
Withdrawal by investigator
|
0
|
1
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Phase 3 Study to Evaluate WR 279,396 vs. Paromomycin Alone to Treat Cutaneous Leishmaniasis (in Tunisia)
Baseline characteristics by cohort
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
Total
n=375 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.4 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
24.6 years
STANDARD_DEVIATION 15.7 • n=7 Participants
|
23.2 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
23.7 years
STANDARD_DEVIATION 15.6 • n=4 Participants
|
|
Age, Customized
Adults
|
63 participants
n=5 Participants
|
66 participants
n=7 Participants
|
61 participants
n=5 Participants
|
190 participants
n=4 Participants
|
|
Age, Customized
Children (12 to 17)
|
24 participants
n=5 Participants
|
33 participants
n=7 Participants
|
35 participants
n=5 Participants
|
92 participants
n=4 Participants
|
|
Age, Customized
Children (5 to 11)
|
38 participants
n=5 Participants
|
26 participants
n=7 Participants
|
29 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
North African
|
125 participants
n=5 Participants
|
125 participants
n=7 Participants
|
125 participants
n=5 Participants
|
375 participants
n=4 Participants
|
|
Total Number of lesions per subject
1 lesion
|
59 participants
n=5 Participants
|
49 participants
n=7 Participants
|
50 participants
n=5 Participants
|
158 participants
n=4 Participants
|
|
Total Number of lesions per subject
More than 1 lesions
|
66 participants
n=5 Participants
|
76 participants
n=7 Participants
|
75 participants
n=5 Participants
|
217 participants
n=4 Participants
|
|
All lesion characteristics
Number of
|
243 lesions
n=5 Participants
|
272 lesions
n=7 Participants
|
282 lesions
n=5 Participants
|
797 lesions
n=4 Participants
|
|
All lesion characteristics
Flat-like
|
0 lesions
n=5 Participants
|
1 lesions
n=7 Participants
|
0 lesions
n=5 Participants
|
1 lesions
n=4 Participants
|
|
All lesion characteristics
Nodule
|
0 lesions
n=5 Participants
|
1 lesions
n=7 Participants
|
0 lesions
n=5 Participants
|
1 lesions
n=4 Participants
|
|
All lesion characteristics
Other
|
3 lesions
n=5 Participants
|
7 lesions
n=7 Participants
|
3 lesions
n=5 Participants
|
13 lesions
n=4 Participants
|
|
All lesion characteristics
Papule
|
0 lesions
n=5 Participants
|
1 lesions
n=7 Participants
|
0 lesions
n=5 Participants
|
1 lesions
n=4 Participants
|
|
All lesion characteristics
Ulcerative
|
240 lesions
n=5 Participants
|
262 lesions
n=7 Participants
|
279 lesions
n=5 Participants
|
781 lesions
n=4 Participants
|
|
Index lesion ulceration area
|
126 mm^2
STANDARD_DEVIATION 121 • n=5 Participants
|
90.2 mm^2
STANDARD_DEVIATION 74.5 • n=7 Participants
|
97.7 mm^2
STANDARD_DEVIATION 112 • n=5 Participants
|
105 mm^2
STANDARD_DEVIATION 105 • n=4 Participants
|
|
Index lesion
Area of ulceration ≤ 100 m^2
|
72 participants
n=5 Participants
|
84 participants
n=7 Participants
|
89 participants
n=5 Participants
|
245 participants
n=4 Participants
|
|
Index lesion
Area of ulceration > 100 mm^2
|
53 participants
n=5 Participants
|
41 participants
n=7 Participants
|
36 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
All lesion ulceration area
|
86.8 mm^2
STANDARD_DEVIATION 107 • n=5 Participants
|
65.6 mm^2
STANDARD_DEVIATION 91.1 • n=7 Participants
|
70.3 mm^2
STANDARD_DEVIATION 91.4 • n=5 Participants
|
73.8 mm^2
STANDARD_DEVIATION 96.5 • n=4 Participants
|
|
All ulcerated lesions
Area of ulceration ≤ 100 m^2
|
175 lesions
n=5 Participants
|
210 lesions
n=7 Participants
|
222 lesions
n=5 Participants
|
607 lesions
n=4 Participants
|
|
All ulcerated lesions
Area of ulceration > 100 mm^2
|
65 lesions
n=5 Participants
|
52 lesions
n=7 Participants
|
57 lesions
n=5 Participants
|
174 lesions
n=4 Participants
|
|
Days before treatment that index lesion was first noticed
|
39.3 days
STANDARD_DEVIATION 25.7 • n=5 Participants
|
39.5 days
STANDARD_DEVIATION 20.0 • n=7 Participants
|
38.9 days
STANDARD_DEVIATION 20.5 • n=5 Participants
|
39.2 days
STANDARD_DEVIATION 22.2 • n=4 Participants
|
|
Days before treatment that index lesion was first noticed (categorical)
≤ 60 days
|
110 participants
n=5 Participants
|
109 participants
n=7 Participants
|
109 participants
n=5 Participants
|
328 participants
n=4 Participants
|
|
Days before treatment that index lesion was first noticed (categorical)
> 60 days
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 42, 98, and 168Population: Modified intention-to-treat (mITT) - all subjects randomized who received at least one treatment of study drug.
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes were as follows: * Initial Clinical Improvement: At least 50% to 99% reduction in the size of the measured lesion from the baseline measurement by the Day 42 evaluation. * Initial Clinical Cure: 100% re-epithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed by 100% re-epithelialization by Day 98. * Relapse: Initial clinical cure followed by re-ulceration by Day 168, or initial clinical improvement followed by lesion enlargement by Day 168. * Final Clinical Cure: Initial clinical cure without relapse through study Day 168.Clinical Failure: Lack of at least initial clinical improvement by Day 42, or relapse.
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Final Clinical Cure Rate
|
101 participants
|
102 participants
|
73 participants
|
SECONDARY outcome
Timeframe: Day 42, 98, and 168Population: Per protocol - all randomized subjects who received at least one treatment of study drug and whose outcomes at Day 42, Day 98 (if applicable) and Day 168 could be assessed. However, a subject was still considered per-protocol if withdrawn early for treatment failure.
Final clinical cure was defined as an index lesion that met the criteria for initial clinical cure without relapse. Definitions for index lesion outcomes as described in the primary outcome measure.
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=124 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=120 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Final Clinical Cure Rate (Per Protocol Dataset)
|
101 participants
|
102 participants
|
73 participants
|
SECONDARY outcome
Timeframe: Day 42Population: mITT dataset
For the first of the above analyses, subjects were considered to have endpoint events at the first assessment on or before Day 42 where complete re-epithelialization occurred at the index lesion that was not followed by a later assessment where ulceration was present. Subjects who did not have complete re-epithelialization by Day 42 or who relapsed after Day 42 were censored in the analysis at the Day 42 assessment. This analysis was only to be conducted through Day 42.
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Estimated Percentage Subjects With Re-epithelialization of the Index Lesion Without Relapse
|
67.2 percentage of participants
Interval 58.5 to 74.8
|
68.8 percentage of participants
Interval 60.2 to 76.3
|
48.8 percentage of participants
Interval 40.2 to 57.5
|
SECONDARY outcome
Timeframe: Days 42, 49, and 98Population: mITT dataset. The data show that 95.8% of the Vehicle-treated subjects remaining in the study at Day 168 (the percentage excludes the 17.6% of subjects who dropped out or were withdrawn early due to treatment failure) had re-epithelialization of the index lesion.
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up
Day 42
|
67.2 percentage of participants
Interval 59.5 to 76.0
|
68.5 percentage of participants
Interval 60.8 to 77.2
|
49.4 percentage of participants
Interval 41.1 to 59.3
|
|
Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up
Day 49
|
72.9 percentage of participants
Interval 65.5 to 81.2
|
81.5 percentage of participants
Interval 74.9 to 88.6
|
57.1 percentage of participants
Interval 48.7 to 67.0
|
|
Estimated Percentage of Subjects With Re-epithelialization of the Index Lesion Without Relapse at Various Times of Follow-up
Day 98
|
94.3 percentage of participants
Interval 90.3 to 98.5
|
99.2 percentage of participants
Interval 97.6 to 100.0
|
90.9 percentage of participants
Interval 85.3 to 96.8
|
SECONDARY outcome
Timeframe: Days 42Population: mITT dataset
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=157 lesions
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=134 lesions
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=115 lesions
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 42
|
51.7 Percentage of lesions
Interval 45.7 to 58.4
|
81.6 Percentage of lesions
Interval 77.0 to 86.4
|
58.1 Percentage of lesions
Interval 52.4 to 64.4
|
SECONDARY outcome
Timeframe: Days 49Population: mITT dataset
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=56 lesions
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=42 lesions
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=67 lesions
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 49
|
81.4 percentage of lesions
Interval 76.6 to 86.5
|
90.4 percentage of lesions
Interval 86.9 to 94.1
|
64.9 percentage of lesions
Interval 59.2 to 71.1
|
SECONDARY outcome
Timeframe: Days 98Population: mITT dataset
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=23 lesions
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=10 lesions
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=36 lesions
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Estimated Percentage of All Treated Ulcerated Lesions Without Relapse at Day 98
|
91.5 percentage of lesions
Interval 88.1 to 95.1
|
98.9 percentage of lesions
Interval 97.6 to 100.0
|
92.2 percentage of lesions
Interval 88.6 to 96.0
|
SECONDARY outcome
Timeframe: Day 42Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Number of Subjects Achieving Initial Clinical Improvement of the Index Lesion
|
105 participants
|
107 participants
|
77 participants
|
SECONDARY outcome
Timeframe: Day 168Population: mITT population
Number of Subjects Achieving Re-epithelialization of the Index Lesion by Day 42 without Relapse from Day 42 Onward, Imputing Relapse for any Subject with a Missing Visit after Day 42
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Number of Subjects Achieving Re-epithelialization of the Index Lesion Without Relapse
|
84 participants
|
84 participants
|
62 participants
|
SECONDARY outcome
Timeframe: Day 168Population: mITT dataset
Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions at Day 42 without Subsequent Relapse from Day 42 Onward,
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Number of Subjects Achieving Re-epithelialization of All Treated Ulcerated Lesions Without Subsequent Relapse
|
83 participants
|
84 participants
|
60 participants
|
SECONDARY outcome
Timeframe: Day 42Population: mITT dataset
Outcome measures
| Measure |
WR 279,396 Topical Treament
n=240 Ulcerated lesions
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=262 Ulcerated lesions
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=279 Ulcerated lesions
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Number of All Ulcerated Lesions Achieving 100% Re-epithelialization by Day 42
|
190 Ulcerated lesions
|
218 Ulcerated lesions
|
160 Ulcerated lesions
|
SECONDARY outcome
Timeframe: Day 168Outcome measures
| Measure |
WR 279,396 Topical Treament
n=125 Participants
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 Participants
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 Participants
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Number of Subjects With a Relapse on or After Day 42
|
4 participants
|
3 participants
|
2 participants
|
Adverse Events
WR 279,396 Topical Treament
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Paromomycin Alone Topical Treatment
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Vehicle Placebo Cream
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WR 279,396 Topical Treament
n=125 participants at risk
WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)
WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing.
|
Paromomycin Alone Topical Treatment
n=125 participants at risk
Paromomycin Alone topical cream (15% paromomycin topical cream)
Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing.
|
Vehicle Placebo Cream
n=125 participants at risk
The cream base without the addition of paromomycin or gentamicin
Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Gastrointestinal disorders
Food poisoning
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
General disorders
Application site bleeding
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
General disorders
Application site erythema
|
4.8%
6/125 • 168 day follow up
|
5.6%
7/125 • 168 day follow up
|
3.2%
4/125 • 168 day follow up
|
|
Gastrointestinal disorders
Application site infection
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
1.6%
2/125 • 168 day follow up
|
|
General disorders
Application site pain
|
0.80%
1/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
General disorders
Application site vesicles
|
24.8%
31/125 • 168 day follow up
|
25.6%
32/125 • 168 day follow up
|
7.2%
9/125 • 168 day follow up
|
|
General disorders
Oedema
|
1.6%
2/125 • 168 day follow up
|
2.4%
3/125 • 168 day follow up
|
4.0%
5/125 • 168 day follow up
|
|
General disorders
Pain
|
1.6%
2/125 • 168 day follow up
|
1.6%
2/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Infections and infestations
Bronchitis
|
4.0%
5/125 • 168 day follow up
|
2.4%
3/125 • 168 day follow up
|
4.0%
5/125 • 168 day follow up
|
|
Infections and infestations
Paronychia
|
1.6%
2/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Pneumonia
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Rhinitis
|
0.80%
1/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Superinfection
|
2.4%
3/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
9.6%
12/125 • 168 day follow up
|
|
Infections and infestations
Upper respiratory tract infection
|
0.80%
1/125 • 168 day follow up
|
1.6%
2/125 • 168 day follow up
|
1.6%
2/125 • 168 day follow up
|
|
Nervous system disorders
Headache
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.2%
4/125 • 168 day follow up
|
2.4%
3/125 • 168 day follow up
|
2.4%
3/125 • 168 day follow up
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.0%
5/125 • 168 day follow up
|
7.2%
9/125 • 168 day follow up
|
4.8%
6/125 • 168 day follow up
|
|
Vascular disorders
Vein pain
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Infections and infestations
Breast abscess
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Erysipelas
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Infections and infestations
Mumps
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Nervous system disorders
Somnolence
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
|
Infections and infestations
Application site inflammation
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
1.6%
2/125 • 168 day follow up
|
|
Immune system disorders
Cellulitis
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/125 • 168 day follow up
|
0.00%
0/125 • 168 day follow up
|
0.80%
1/125 • 168 day follow up
|
Additional Information
Division of Regulated Activies and Compliance
US Army Medical Materiel Development Activity (USAMMDA)
Phone: 301-619-0317
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place