Trial Outcomes & Findings for Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis (NCT NCT01140191)

NCT ID: NCT01140191

Last Updated: 2019-11-22

Results Overview

Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2019-11-22

Participant Flow

Recruitment was held 06Sep13 thru 17Dec2013 at study center WRNMMC at Bethesda 8901 Wisconsin Ave., Building 7, 1st Floor Bethesda, MD 20889

Statistical analysis was not performed as only a single subject was enrolled. No PK analysis was performed as this subject elected not to participate in the PK part of the study.

Participant milestones

Measure	WR 279,396 All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis

Baseline characteristics by cohort

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
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
Region of Enrollment United States	1 Participants n=5 Participants
Number of Lesions	1 Lesions n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Analysis was per protocol

Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Number of Adverse Events	3 Adverse Events

PRIMARY outcome

Timeframe: Day 60

Population: Analysis per protocol

Number of participants with 100% re-epithelialization of index lesion by nominal Day 60

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
100% Re-epithelialization of Index Lesion by Nominal Day 60	1 Participants

PRIMARY outcome

Timeframe: 60-100 days

Population: Analysis per protocol

Number of participants with > 50% re-epithelialization of index lesion by Day 60 followed by complete re-epithelialization of index lesion on or before nominal Day 100;

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Number of Participants Demonstrating Initial Clinical Improvements	1 Participants

PRIMARY outcome

Timeframe: 60-100 days

Population: Analysis per protocol

Number of participants with no relapses of lesion between 60 and 100 days. Relapse is defined as a 10% or greater increase in the area of ulceration of the index lesion or a shift from 100% re-epithelialization to < 100% re-epithelialization of the index lesion at Day 100 for those subjects that had 100% re-epithelialization of the index lesion at nominal Day 60 or before

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100	0 Participants

SECONDARY outcome

Timeframe: 100 days

Population: Analysis per protocol

Number of participants with 100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Cures of All Other Lesions	0 Participants

SECONDARY outcome

Timeframe: 100 days

Population: Analysis per protocol

Number of participants with complete cure of index lesion by day 100. Cure rate is defined as 100% re-epithelialization of an ulcerated lesion

Outcome measures

Measure	WR 279,396 n=1 Participants All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Complete Cure of Index Lesion by Day 100	1 Participants

Adverse Events

WR 279,396

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	WR 279,396 n=1 participants at risk All subjects in this one-arm study will receive topical WR 279,396 WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
Nervous system disorders Headache	100.0% 1/1 • Number of events 1 • 100 days Duration of treatment was 20 days, total days for event reporting was 100.
Infections and infestations Upper Respiratory Tract Infection	100.0% 1/1 • Number of events 1 • 100 days Duration of treatment was 20 days, total days for event reporting was 100.
General disorders Application Site Pruritus	100.0% 1/1 • Number of events 1 • 100 days Duration of treatment was 20 days, total days for event reporting was 100.

Additional Information

COL Glenn W. Wortman

Walter Reed National Military Medical Center (WRNMMC)

Phone: 301-295-6400

Email: glenn.wortmann@amedd.army.mil

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place