Trial Outcomes & Findings for Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396 (NCT NCT00657917)
NCT ID: NCT00657917
Last Updated: 2019-01-22
Results Overview
Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
180 days
Results posted on
2019-01-22
Participant Flow
Recruitment was conducted at Walter Reed Army Medical Center, Washington, DC. One subject was enrolled.
Participant milestones
| Measure |
Paromomycin +Gentamicin Topical Cream
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
Baseline characteristics by cohort
| Measure |
Paromomycin +Gentamicin Topical Cream
n=1 Participants
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.
Appearance of complete (100%) epithelialization of a skin lesion at day 50+2 weeks, or the estimated 50%-99% re-epithelialization by day 50+2 weeks followed by complete eipithelialization by day 100+2 weeks, with both categories without relapse by day 180+30 days. Ulcer measured in millimeters.
Outcome measures
| Measure |
Paromomycin +Gentamicin Topical Cream
n=1 Participants
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
|
|---|---|
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The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Screening
|
2,142 Surface area in millimeters squared
|
|
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Day 20+3
|
1,488 Surface area in millimeters squared
|
|
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Day 50+14
|
1,400 Surface area in millimeters squared
|
|
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Day 180+30 (photos only)
|
0 Surface area in millimeters squared
|
SECONDARY outcome
Timeframe: 180 daysPopulation: Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.
Evaluate the number of relapses occurring by day 180
Outcome measures
| Measure |
Paromomycin +Gentamicin Topical Cream
n=1 Participants
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
|
|---|---|
|
Number of Relapses
|
0 Number of relapses
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SECONDARY outcome
Timeframe: 180 daysPopulation: Ultimately, the planned statistical analysis could not be performed because only one patient was enrolled in the study.
Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's
Outcome measures
| Measure |
Paromomycin +Gentamicin Topical Cream
n=1 Participants
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
|
|---|---|
|
Safety and Tolerability (SAE's and AE's)
AEs Considered Related to Study Drug
|
9 Number of AE's
|
|
Safety and Tolerability (SAE's and AE's)
AE's Not Considered Related to Study Drug
|
23 Number of AE's
|
Adverse Events
Paromomycin +Gentamicin Topical Cream
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paromomycin +Gentamicin Topical Cream
n=1 participants at risk
WR279,396 topically twice a day for 20 days
Paromomycin +Gentamicin topical cream: WR297,396 for treatment of patients with parasitologically confirmed, primarily ulcerative, Old World CL, who had either failed pentavalent antimony treatment, or who where ineligible for pentavalent antimony therapy.
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|---|---|
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Musculoskeletal and connective tissue disorders
Left calf pain
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
General disorders
Flu-like symptoms
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Gastrointestinal disorders
Gastroenteritis
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
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|
Investigations
Elevated BP readings
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
General disorders
Right gluteal pain
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Skin and subcutaneous tissue disorders
Right groin rash
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Metabolism and nutrition disorders
Left foot edema
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Infections and infestations
Upper respiratory infection
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Nervous system disorders
Burning sensation at site
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
General disorders
Worsening pain at ulcer site
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Injury, poisoning and procedural complications
Vesicle formation at ulcer site
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Cardiac disorders
Intermittent tachycardia
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Respiratory, thoracic and mediastinal disorders
Blood-tinged secretions from nares
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Investigations
Decreased sodium level
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Vascular disorders
Insufficient hypertension control
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
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|
Skin and subcutaneous tissue disorders
Cracked skin surrounding ulcer area
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Skin and subcutaneous tissue disorders
Erosive areas around ulcer border
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Skin and subcutaneous tissue disorders
Rash above surrounding area of ulcer/lesion
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Injury, poisoning and procedural complications
Blister-like formation above border of ulcer/lesion
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Injury, poisoning and procedural complications
Small cut on left shin
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Nervous system disorders
Numbness (slight) above ulcer/lesion
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Blood and lymphatic system disorders
Lymphadenopathy (right inguinal area)
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
General disorders
Incomplete healing of ulcer/lesion
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Blood and lymphatic system disorders
Persistent lymphedema, left lower extremity
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Vascular disorders
Hyperemic left leg
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Metabolism and nutrition disorders
Edema, left leg to mid thigh
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Investigations
Elevated percentage of monocytes in blood
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Investigations
Elevated percentage of WBC in urine
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
|
|
Surgical and medical procedures
Increased drainage from wound
|
100.0%
1/1 • Number of events 1 • 180 Days
Solicited and unsolicited AEs were collected throughout the 20-day treatment period. Follow-up contacts to assess efficacy and safety occurred on study days 50+14, 100+14, and 180+30.
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Additional Information
COL Naomi Aronson MC
Uniformed Services University of the Heralth Sciences
Phone: 301-295-3621
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place