Leishmaniasis, CutaneousPhase 2WRNMMCNCT01140191
Safety, Efficacy, and PK of Topical Paromomycin/Gentamicin Cream for Treatment of Cutaneous Leishmaniasis
A Phase 2 study testing WR 279,396 in people with Leishmaniasis, Cutaneous, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leishmaniasis, Cutaneous
- What is being tested?
- WR 279,396
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be male or female military health care beneficiary of any race or ethnicity and at least 18 years of age
- Subjects must give written informed consent.
- Subjects must have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue; 3) positive polymerase chain reaction (PCR) assay; and/or 4) prior diagnosis of CL within 14 days of the start of treatment.
- Subjects must have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion (Larger lesions will be accepted for treatment, but these will not be included in the primary evaluation of efficacy).
- Subjects must be willing to forego other forms of treatments for CL including other investigational treatment during the study.
- Subjects must be capable of understanding and complying with the protocol (in the opinion of the investigator).
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- Subjects must expect to be located in the Washington DC metropolitan area for at least the duration of the screening, 20-day treatment period, and Day 28 +/- 2 days follow-up visit.
- Subjects who are female and of child-bearing potential, must have a negative pregnancy test during screening and agree to use an acceptable method of birth control during the treatment phase and for 1 month after treatment is completed.
- Subject has adequate venous access for blood draws, if consented to the PK part of study.
Who cannot join
- Subject has had a prior diagnosis of leishmaniasis where all lesions had healed.
- Subject has only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion <1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drug topically.
- Subject has a lesion due to Leishmania that involves the mucosa or palate.
- Subject has signs and symptoms of disseminated disease.
- Subject is a female who is breast-feeding.
- Subject has an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
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- Subject has significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine, AST, or ALT greater than the upper limit of normal as defined by the clinical laboratory normal ranges.
- Subject has received treatment for leishmaniasis including thermosurgery (ThermoMed™) or any medication with pentavalent antimony including sodium stibogluconate (Pentostam), meglumine antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and amphotericin B deoxycholate); WR 279,396; or other medications containing paromomycin (administered parenterally or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole; ketoconazole; pentamidine; or allopurinol within 4 weeks of starting study treatment.
- Subject has a history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
- Subject has any other topical disease/condition which interferes with the objectives of this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889
About this study
Official title: An Open-Label Clinical Study to Examine the Safety, Efficacy, and Pharmacokinetics of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis at Walter Reed National Military Medical Center (WRNMMC)
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).
Read the detailed description
Subjects will be screened over a period of up to 14 days prior to first treatment, and will receive treatment once daily for 20 days. Safety will be assessed by monitoring AEs, lesion site reactions, vital signs, hematology, and blood chemistry parameters.
Complete cure of ulcerated lesions is defined as 100% re-epithelialization or a measurement of ulceration of 0 x 0 mm. non-ulcerated treated lesions will also be measured to monitor total area of exposure of lesions to study drug and will be evaluated for cure (the absence of raised area on the skin).
Follow-up evaluations will be at 28 +2 days, 60 +7 days and 100 +14 days.
- Conditions
- Leishmaniasis, Cutaneous
- Being tested
- WR 279,396
- Keywords
- leishmaniasis, cutaneous, WR 279,396, paromomycin, gentamicin, pharmacokinetics, safety, efficacy, military
- Medical subject headings
- Leishmaniasis, Cutaneous, Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WR 279,396Drug
Also called Topical Paromomycin/Gentamicin Cream
Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
| Study group | Role | What they receive |
|---|---|---|
| WR 279,396 | Experimental | All subjects in this one-arm study will receive topical WR 279,396 Receives: Drug: WR 279,396 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs
Measured: 3 months
100% Re-epithelialization of Index Lesion by Nominal Day 60
Number of participants with 100% re-epithelialization of index lesion by nominal Day 60
Measured: Day 60
Number of Participants Demonstrating Initial Clinical Improvements
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;
Measured: 60-100 days
Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100
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
Measured: 60-100 days
Secondary outcomes (2)
Cures of All Other Lesions
Number of participants with 100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions
Measured: 100 days
Complete Cure of Index Lesion by Day 100
Number of participants with complete cure of index lesion by day 100. Cure rate is defined as 100% re-epithelialization of an ulcerated lesion
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionSep 2014
Why it stopped: This study was closed due to lack of enrollment (only one subject enrolled)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leishmaniasis, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Timothy Whitman, DO, USN, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140191
- Sponsor's protocol ID
- A-16049; S-10-0007
- Other IDs
- USAMMDA Protocol Number
- Acronym
- WRNMMC
- Status last verified
- Nov 2019
- First submitted
- 7 Jun 2010
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Clinical Study to Examine the Safety, Efficacy, and Pharmacokinetics of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis at Walter Reed National Military Medical Center (WRNMMC)
- ClinicalTrials.gov ID
- NCT01140191
- Acronym / sponsor ID
- WRNMMC / A-16049; S-10-0007
- Conditions
- Leishmaniasis, Cutaneous
- Keywords
- leishmaniasis, cutaneous, WR 279,396, paromomycin, gentamicin, pharmacokinetics, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed due to lack of enrollment (only one subject enrolled)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 22 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are to evaluate the safety, pharmacokinetics (PK), and efficacy of open label treatment with WR 279,396 (Topical Paromomycin/Gentamicin Cream)in subjects with cutaneous leishmaniasis (CL).
Detailed description
Subjects will be screened over a period of up to 14 days prior to first treatment, and will receive treatment once daily for 20 days. Safety will be assessed by monitoring AEs, lesion site reactions, vital signs, hematology, and blood chemistry parameters.
Complete cure of ulcerated lesions is defined as 100% re-epithelialization or a measurement of ulceration of 0 x 0 mm. non-ulcerated treated lesions will also be measured to monitor total area of exposure of lesions to study drug and will be evaluated for cure (the absence of raised area on the skin).
Follow-up evaluations will be at 28 +2 days, 60 +7 days and 100 +14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WR 279,396 | Experimental | Drug: WR 279,396All subjects in this one-arm study will receive topical WR 279,396 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be male or female military health care beneficiary of any race or ethnicity and at least 18 years of age
- Subjects must give written informed consent.
- Subjects must have a diagnosis of CL in at least one lesion by at least one of the following methods: 1) positive culture for promastigotes; 2) microscopic identification of amastigotes in stained lesion tissue; 3) positive polymerase chain reaction (PCR) assay; and/or 4) prior diagnosis of CL within 14 days of the start of treatment.
- Subjects must have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion (Larger lesions will be accepted for treatment, but these will not be included in the primary evaluation of efficacy).
- Subjects must be willing to forego other forms of treatments for CL including other investigational treatment during the study.
Key exclusion criteria (10 listed)
- Subject has had a prior diagnosis of leishmaniasis where all lesions had healed.
- Subject has only a single lesion whose characteristics include any of the following: verrucous or nodular lesion (non-ulcerative), lesion <1 cm in its greatest diameter, lesion in a location that in the opinion of the Investigator is difficult to maintain application of study drug topically.
- Subject has a lesion due to Leishmania that involves the mucosa or palate.
- Subject has signs and symptoms of disseminated disease.
- Subject is a female who is breast-feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WR 279,396Also: Topical Paromomycin/Gentamicin CreamTopical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days | Drug | WR 279,396 |
Primary outcome
Number of Adverse Events
Time frame: 3 months
Application site reactions including elicited question about pain, and clinician examination for erythema/redness and swelling/edema Blood chemistries and hematology Vital signs
100% Re-epithelialization of Index Lesion by Nominal Day 60
Time frame: Day 60
Number of participants with 100% re-epithelialization of index lesion by nominal Day 60
Number of Participants Demonstrating Initial Clinical Improvements
Time frame: 60-100 days
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;
Number of Participants With No Relapse of Index Lesion Between Nominal Day 60 and 100
Time frame: 60-100 days
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
2 secondary outcomes
Cures of All Other Lesions
Time frame: 100 days
Complete Cure of Index Lesion by Day 100
Time frame: 100 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Whitman, DO, USN principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WR 279,396 in people with Leishmaniasis, Cutaneous, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.