TerminatedNCT01494350Updated Dec 19, 2014Results posted

WR 279,396 Open Label Treatment Protocol in Tunisia

A Phase 2 interventional study of WR 279,396 topical cream in Cutaneous Leishmaniasis, sponsored by U.S. Army Medical Research and Development Command. Terminated at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-19.

Sponsored by U.S. Army Medical Research and Development Command · Phase 2, Interventional, and Treatment

Why this study was terminated

This study was closed prematurely due study team travel restrictions.

Phase: Phase 2
Study type: Interventional
Enrollment: 50
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

The U.S. Army has recently completed a Phase 3 clinical trial in Tunisia. This is an open-label single site trial designed to expand our safety database and capture additional efficacy (final clinical cure rate of an index lesion) of WR 279,396 Topical Cream in Tunisian subjects with non-complicated, non-severe Cutaneous Leishmaniasis (CL). Subjects will be patients who visit Ministry of Health sponsored clinics in Tunisia who present with at least one CL lesion that is ulcerated and amenable to topical treatment. Potential trial subjects will be consented and screened for eligibility including medical history, physical exam, lesion parasitology, and renal and liver function tests. If eligible for the study, subjects will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) (target n = 110). The cream will be applied topically to all CL lesions once daily for 20 days by an investigator or study nurse. If a subject develops a new lesion during the study, the new lesion may also be treated with the topical cream.

Read the detailed description

Subjects will have an in-clinic follow-up on Days 28 +/- 2 days, 42 +/- 4 days and 98 +/- 8 days to assess safety and cure rates. Safety variables including adverse events (AEs) and serious adverse events (SAEs) will be collected through Day 98. For the primary efficacy evaluation, the index ulcerative lesion will be assessed for clinical response by measurement of the length and width of area of ulceration. All other treated lesions will also be assessed for cure as secondary efficacy endpoints with ulcerated and non-ulcerated lesions being evaluated independently. An ulcerated lesion will be considered to be completely cured if 100% reepithelialization is observed. The length and width of non-ulcerated lesions (nodules, plaques) will also be measured and evaluated for cure (ie, absence of signs of an active lesion). The primary efficacy endpoint is the final clinical cure rate calculated by the number of index lesions that had 100% reepithelialization at Day 98 divided by the total number of index lesions that received at least one topical treatment of WR 279,396.

Conditions studied

Cutaneous Leishmaniasis

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Keywords

cutaneous leishmaniasis
topical treatment
Tunisia

In context

Leishmaniasis

185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 133 interventional studies indexed under Leishmaniasis.

Browse Leishmaniasis studies →

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

At least 18 years of age
Subject has a diagnosis of CL in at least one lesion by at least one of the following methods: 1) microscopic identification of amastigotes in stained lesion tissue, or 2) positive culture for promastigotes.
Subject has a parasitologically confirmed lesion that satisfies the following criteria for an Index lesion:
- ulcerative in character
- lesion size ≥ 1 cm and ≤5 cm (including the area of induration surrounding the lesion)
- not located on the ear, or on a location that in the opinion of the PI is difficult to maintain application of study drug topically.
Subject has \< 7 leishmaniasis total lesions.
Subject is willing to forego other forms of treatments for CL including other investigational treatments during the study.
In the opinion of the investigator, the subject (or their legal guardian) is capable of understanding and complying with the protocol.

Exclusion criteria

Exclusion Criteria:

Female with a positive serum pregnancy test or who is breast feeding.
History of clinically significant medical problems in the investigator's judgment that might interact, either negatively or positively, with topical treatment of leishmaniasis including any immunocompromising condition.
Age adjusted blood creatinine or blood urea nitrogen (BUN) levels indicative of clinically significant renal disease or aspartate amino transferase (AST), alanine amino transferase (ALT), or total bilirubin that suggest clinically significant hepatic impairment as judged by the PI or subinvestigator. Note: This study is designed to evaluate populations who may have some renal or hepatic dysfunction as the drug has not been shown to have serum levels that would be expected to show renal or hepatic toxicity and treatment of the general population presenting with CL is highly desired based on its safety profile compared to other leishmanial drugs.
Evidence of disseminated leishmaniasis.
Received treatment for leishmaniasis with antimonials or any medication likely, in the opinion of the PI, to modify the course of the Leishmania infection within 56 days of starting study treatments.
History of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Experimental
WR 279,396 topical cream
120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream
Drug: WR 279,396 topical cream

Interventions

DrugWR 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.
Also known as: WR 279, 396, Topical Paromomycin + Gentamicin Cream

What researchers measure

Primary outcomes

Final Clinical Cure Rate for the Index Lesion
Number of index lesions with 100% reepithelialization at Day 98.
Time frame: Final clincial cure is measured at day 98

Secondary outcomes

Area of Index Lesions Throughout the Study
Area (mm\^2) of index lesion on Days 0, 20, 28, 42, and 98.
Time frame: Measured at day 0, 20, 28, 42, and 98
Number of Index Lesions With Reepithelialization Throughout the Study
Number of index lesions with 100% reepithelialization on Days 28 and 42.
Time frame: Measured at day 28 and 42
Area of All Ulcerated Lesions Throughout the Study
Area of all ulcerated lesions on Days 20, 28, 42, and 98.
Time frame: Measured at day 20, 28, 42 and 98
Number of All Ulcerated Lesions With Reepithelialization on Day 28
Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28
Time frame: Measured on day 28

Results

Posted Dec 19, 2014

Limitations and caveats

This study was closed prematurely due study team and travel restrictions but not due to any safety issues with the study subjects. Only a total of 50 of the 110 planned subjects were enrolled in the study.

Participant flow

184 total screened and there were 134 screen failures.

Participant flow — Overall Study
Milestone	WR 279,396 Topical Cream
Started	50
Completed	49
Not completed	1
Withdrew: Worsening of lesion	1

Outcome measures

PrimaryFinal Clinical Cure Rate for the Index Lesion

Number of index lesions with 100% reepithelialization at Day 98.

Time frame:: Final clincial cure is measured at day 98
Reported as:: Number · lesions

Final Clinical Cure Rate for the Index Lesion
lesions	WR 279,396 Topical Cream
Final Clinical Cure Rate for the Index Lesion	48

SecondaryArea of Index Lesions Throughout the Study

Area (mm\^2) of index lesion on Days 0, 20, 28, 42, and 98.

Time frame:: Measured at day 0, 20, 28, 42, and 98
Reported as:: Mean · mm^2

Area of Index Lesions Throughout the Study
mm^2	WR 279,396 Topical Cream
Baseline (Day 0)	121 ± 106
Day 20	393 ± 315
Day 28	203 ± 238
Day 42	38.9 ± 83.2
Day 98	7.88 ± 55.1

SecondaryNumber of Index Lesions With Reepithelialization Throughout the Study

Number of index lesions with 100% reepithelialization on Days 28 and 42.

Time frame:: Measured at day 28 and 42
Reported as:: Number · lesions

Number of Index Lesions With Reepithelialization Throughout the Study
lesions	WR 279,396 Topical Cream
Day 28	8
Day 42	28

SecondaryArea of All Ulcerated Lesions Throughout the Study

Area of all ulcerated lesions on Days 20, 28, 42, and 98.

Time frame:: Measured at day 20, 28, 42 and 98
Reported as:: Mean · mm^2

Area of All Ulcerated Lesions Throughout the Study
mm^2	WR 279,396 Topical Cream
Baseline (Day 0)	82.6 ± 90.4
Day 20	288 ± 275
Day 28	149 ± 198
Day 42	22.1 ± 63.3
Day 98	4.02 ± 39.4

SecondaryNumber of All Ulcerated Lesions With Reepithelialization on Day 28

Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28

Time frame:: Measured on day 28
Reported as:: Number · lesions

Number of All Ulcerated Lesions With Reepithelialization on Day 28
lesions	WR 279,396 Topical Cream
Number of All Ulcerated Lesions With Reepithelialization on Day 28	23

Adverse events

Collected over 98 days. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
WR 279,396 Topical Cream	—	0/50 (0%)	39/50 (78%)

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	WR 279,396 Topical Cream
Application site vesiclesGeneral disorders	27/50
Application site erythemaGeneral disorders	12/50
Dermatitis contactSkin and subcutaneous tissue disorders	10/50
Skin irritationSkin and subcutaneous tissue disorders	9/50
Bronchitis acuteInfections and infestations	2/50
OedemaGeneral disorders	1/50
PainGeneral disorders	1/50
SuperinfectionGeneral disorders	1/50
ScratchInjury, poisoning and procedural complications	1/50
Thermal burnInjury, poisoning and procedural complications	1/50

Baseline characteristics

modified intent to treat (mITT)/safety subjects

Age, Continuous
Age, Continuous(years)	WR 279,396 Topical Cream
Mean	38.7 ± 13.1

Sex: Female, Male
Sex: Female, Male(Participants)	WR 279,396 Topical Cream
Female	30
Male	20

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	WR 279,396 Topical Cream
North African	50

Number of lesions per subject
Number of lesions per subject(lesions)	WR 279,396 Topical Cream
Mean	1.96 ± 1.48

Study locations

1 site

Central Clinic-Sidi Bouzid
Tunis, Tunisia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01494350
Lead sponsor: U.S. Army Medical Research and Development Command
Collaborators: Walter Reed Army Institute of Research (WRAIR)
Responsible party: Sponsor
First posted: Dec 19, 2011
Start date: Dec 2011
Primary completion: Jun 2012
Completion: Jun 2012
Results posted: Dec 19, 2014
Last update: Dec 19, 2014

Study contacts

Afif Ben Salah, M.D., Ph.D.

principal investigator · Institute Pasteur Tunisia

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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