Trial Outcomes & Findings for WR 279,396 Open Label Treatment Protocol in Tunisia (NCT NCT01494350)
NCT ID: NCT01494350
Last Updated: 2014-12-19
Results Overview
Number of index lesions with 100% reepithelialization at Day 98.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Final clincial cure is measured at day 98
Results posted on
2014-12-19
Participant Flow
184 total screened and there were 134 screen failures.
Participant milestones
| Measure |
WR 279,396 Topical Cream
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
WR 279,396 Topical Cream
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Overall Study
Worsening of lesion
|
1
|
Baseline Characteristics
WR 279,396 Open Label Treatment Protocol in Tunisia
Baseline characteristics by cohort
| Measure |
WR 279,396 Topical Cream
n=50 Participants
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Age, Continuous
|
38.7 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
North African
|
50 participants
n=93 Participants
|
|
Number of lesions per subject
|
1.96 lesions
STANDARD_DEVIATION 1.48 • n=93 Participants
|
PRIMARY outcome
Timeframe: Final clincial cure is measured at day 98Population: modified intent to treat (mITT)
Number of index lesions with 100% reepithelialization at Day 98.
Outcome measures
| Measure |
WR 279,396 Topical Cream
n=50 index lesions
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Final Clinical Cure Rate for the Index Lesion
|
48 lesions
|
SECONDARY outcome
Timeframe: Measured at day 0, 20, 28, 42, and 98Population: modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18.
Area (mm\^2) of index lesion on Days 0, 20, 28, 42, and 98.
Outcome measures
| Measure |
WR 279,396 Topical Cream
n=49 Index lesions
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Area of Index Lesions Throughout the Study
Baseline (Day 0)
|
121 mm^2
Standard Deviation 106
|
|
Area of Index Lesions Throughout the Study
Day 20
|
393 mm^2
Standard Deviation 315
|
|
Area of Index Lesions Throughout the Study
Day 28
|
203 mm^2
Standard Deviation 238
|
|
Area of Index Lesions Throughout the Study
Day 42
|
38.9 mm^2
Standard Deviation 83.2
|
|
Area of Index Lesions Throughout the Study
Day 98
|
7.88 mm^2
Standard Deviation 55.1
|
SECONDARY outcome
Timeframe: Measured at day 28 and 42Population: modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.
Number of index lesions with 100% reepithelialization on Days 28 and 42.
Outcome measures
| Measure |
WR 279,396 Topical Cream
n=49 Index lesions
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Number of Index Lesions With Reepithelialization Throughout the Study
Day 28
|
8 lesions
|
|
Number of Index Lesions With Reepithelialization Throughout the Study
Day 42
|
28 lesions
|
SECONDARY outcome
Timeframe: Measured at day 20, 28, 42 and 98Population: modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18.
Area of all ulcerated lesions on Days 20, 28, 42, and 98.
Outcome measures
| Measure |
WR 279,396 Topical Cream
n=96 lesions
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Area of All Ulcerated Lesions Throughout the Study
Baseline (Day 0)
|
82.6 mm^2
Standard Deviation 90.4
|
|
Area of All Ulcerated Lesions Throughout the Study
Day 20
|
288 mm^2
Standard Deviation 275
|
|
Area of All Ulcerated Lesions Throughout the Study
Day 28
|
149 mm^2
Standard Deviation 198
|
|
Area of All Ulcerated Lesions Throughout the Study
Day 42
|
22.1 mm^2
Standard Deviation 63.3
|
|
Area of All Ulcerated Lesions Throughout the Study
Day 98
|
4.02 mm^2
Standard Deviation 39.4
|
SECONDARY outcome
Timeframe: Measured on day 28Population: modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.
Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
Outcome measures
| Measure |
WR 279,396 Topical Cream
n=96 Lesions
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
Number of All Ulcerated Lesions With Reepithelialization on Day 28
|
23 lesions
|
Adverse Events
WR 279,396 Topical Cream
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WR 279,396 Topical Cream
n=50 participants at risk
WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
|
|---|---|
|
General disorders
Application site erythema
|
24.0%
12/50 • 98 days
|
|
General disorders
Application site vesicles
|
54.0%
27/50 • 98 days
|
|
General disorders
Oedema
|
2.0%
1/50 • 98 days
|
|
General disorders
Pain
|
2.0%
1/50 • 98 days
|
|
Infections and infestations
Bronchitis acute
|
4.0%
2/50 • 98 days
|
|
General disorders
Superinfection
|
2.0%
1/50 • 98 days
|
|
Injury, poisoning and procedural complications
Scratch
|
2.0%
1/50 • 98 days
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.0%
1/50 • 98 days
|
|
Investigations
Alanine aminotrasnsferase increased
|
2.0%
1/50 • 98 days
|
|
Investigations
Blood urea increased
|
2.0%
1/50 • 98 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
20.0%
10/50 • 98 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
18.0%
9/50 • 98 days
|
Additional Information
Afif Ben Salah, MD, PhD
Institut Pasteur of Tunis
Phone: 011-216-71-792-429
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place