Cutaneous LeishmaniasisPhase 2NCT00657917
Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
A Phase 2 study testing Paromomycin +Gentamicin topical cream in people with Cutaneous Leishmaniasis, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- Paromomycin +Gentamicin topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2006to 24 Jun 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parasitologically confirmed, primarily ulcerative, Old World CL, in a patient who had either failed pentavalent antimony treatment, or who was ineligible for pentavalent antimony therapy.
- Military health care beneficiary 18 years of age or greater, unless active military in which case, 17 years is the minimum age
- Proven parasitological diagnosis by culture, PCR or microscopy in at least one skin lesion
- Lesions primarily ulcerative (i.e., not verrucous or nodular)
- Written informed consent to participate in protocol
- Negative pregnancy test within 72 hours of starting protocol
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- Agrees to take precautions not to become pregnant or father a child for at least two months after completion of treatment with WR 279,396
- Cutaneous leishmaniasis acquired in Southwest Central Asia/Middle East*
- Inadequate response to treatment with pentavalent antimony or medical condition that precludes the use of pentavalent antimony
Who cannot join
- Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient
- any leishmanial lesion on mucosal surface
- Presence of signs or symptoms of peripheral neuropathic myasthenia gravis, neuromuscular block
- Routinely taking nephrotoxic or ototoxic medications
- Disseminated disease defined as clinically significant subcutaneous nodules that are in the lymphatic drainage tract for the skin lesion with regional adenopathy > 1 cm
- Abnormal Romberg test at baseline
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- Clinically significant medical problems of the kidney or liver as determined by history and by the following laboratory studies:
- Kidney: Creatinine > 2x the upper limit of normal
- Liver: ASTor ALT >4x the upper limit fo normal
- This includes "L. major," "L. tropica," and "L. infantum" with over 98% of cases in U.S. military in 2002-2004 being "L. major"
- An inadequate response to treatment with pentavalent antimony includes patients who show no or little improvement during a 15-20 day treatment course, those that initially epithelialize but later show signs of breakdown/ ulceration or develop new lesions. In general, for those with initial treatment response, would recommend waiting for approximately two months after pentavalent antimony and if lesion is not epithelialized at that time, consideration for further therapy is advised.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.
Read the detailed description
Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- Paromomycin +Gentamicin topical cream
- Keywords
- leishmaniasis, cutaneous, Old World, Leishmania major, Treatment
- 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.
Paromomycin +Gentamicin topical creamDrug
Also called WR279,396
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.
| Study group | Role | What they receive |
|---|---|---|
| Paromomycin +Gentamicin topical cream | Experimental | WR279,396 topically twice a day for 20 days Receives: Drug: Paromomycin +Gentamicin topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
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.
Measured: 180 days
Secondary outcomes (2)
Number of Relapses
Evaluate the number of relapses occurring by day 180
Measured: 180 days
Safety and Tolerability (SAE's and AE's)
Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study start20 Dec 2006
- Primary completion8 Jun 2007
- Study completion24 Jun 2010
Why it stopped: No subjects were enrolled since the first subject completed the study 08Jun2007
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 Cutaneous LeishmaniasisStudies 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 Army Medical Center
- Responsible party
- Sponsor
- Investigators
- COL Naomi Aronson, M.D., Principal investigator, Uniformed Services Univ of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657917
- Sponsor's protocol ID
- A-13225
- Status last verified
- Aug 2018
- First submitted
- 22 Feb 2008
- Last updated
- 22 Jan 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 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Treatment of Recalcitrant Ulcerative Old World Leishmaniasis With WR 279,396
- ClinicalTrials.gov ID
- NCT00657917
- Acronym / sponsor ID
- A-13225
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- leishmaniasis, cutaneous, Old World, Leishmania major, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No subjects were enrolled since the first subject completed the study 08Jun2007
- Enrolment
- 1 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Medical Center
- Study start
- 20 Dec 2006 (actual)
- Primary completion
- 8 Jun 2007 (actual)
- Study completion
- 24 Jun 2010 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Posted 22 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this protocol is to treat laboratory confirmed cutaneous leishmaniasis with WR 279,396 in military health care beneficiaries. In this study "cutaneous leishmaniasis" is defined as Old World Leishmaniasis if acquired in the Southwest Central Asia/Middle East.
Detailed description
Up to 10 volunteers, who are military health care beneficiaries, with a diagnosis of Old World cutaneous leishmaniasis who have failed pentavalent antimony or are not eligible to be treated with pentavalent antimony, will be treated with WR 279,396 (topical paromomycin-gentamicin-AQIC) twice a day for 20 days. Primary endpoint will be the appearance of complete epithelialization of each skin lesion by Day 50+/-2 weeks, or estimated 50%-99% re-epithelialization by Day 50+/-2 weeks followed by complete epithelialization by Day 100+/-2 weeks,with both categories without relapse by Day 180+/-30 days. Efficacy will be evaluated by clinical appearance assessed by study investigator and documented with photographs of the treated skin lesions. Toxicity will be evaluated by local adverse reactions and by laboratory signs of systemic toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paromomycin +Gentamicin topical cream | Experimental | Drug: Paromomycin +Gentamicin topical creamWR279,396 topically twice a day for 20 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Parasitologically confirmed, primarily ulcerative, Old World CL, in a patient who had either failed pentavalent antimony treatment, or who was ineligible for pentavalent antimony therapy.
- Military health care beneficiary 18 years of age or greater, unless active military in which case, 17 years is the minimum age
- Proven parasitological diagnosis by culture, PCR or microscopy in at least one skin lesion
- Lesions primarily ulcerative (i.e., not verrucous or nodular)
- Written informed consent to participate in protocol
Key exclusion criteria (11 listed)
- Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides in the patient
- any leishmanial lesion on mucosal surface
- Presence of signs or symptoms of peripheral neuropathic myasthenia gravis, neuromuscular block
- Routinely taking nephrotoxic or ototoxic medications
- Disseminated disease defined as clinically significant subcutaneous nodules that are in the lymphatic drainage tract for the skin lesion with regional adenopathy > 1 cm
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 |
|---|---|---|
| Paromomycin +Gentamicin topical creamAlso: WR279,396WR297,396 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. | Drug | Paromomycin +Gentamicin topical cream |
Primary outcome
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse
Time frame: 180 days
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.
2 secondary outcomes
Number of Relapses
Time frame: 180 days
Safety and Tolerability (SAE's and AE's)
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 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.
COL Naomi Aronson, M.D. principal investigator
Uniformed Services Univ of the Health Sciences
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 Paromomycin +Gentamicin topical cream in people with Cutaneous Leishmaniasis, 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 11 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 Jan 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 Jan 2019). 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?
The Appearance of Complete Epithelialization of Ulcerative Lesions Caused by Old World Cutaneous Leishmaniasis With no Relapse (time frame: 180 days). 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 Jan 2019.