Cutaneous LeishmaniasisPhase 2NCT01494350
WR 279,396 Open Label Treatment Protocol in Tunisia
A Phase 2 study testing WR 279,396 topical cream in people with Cutaneous Leishmaniasis, run by U.S. Army Medical Research and Development Command at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- WR 279,396 topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- Dec 2011to Jun 2012
- 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )
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
- Cutaneous Leishmaniasis
- Being tested
- WR 279,396 topical cream
- Keywords
- cutaneous leishmaniasis, topical treatment, Tunisia
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WR 279,396 topical creamDrug
Also called WR 279, 396, Topical Paromomycin + Gentamicin 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.
| Study group | Role | What they receive |
|---|---|---|
| WR 279,396 topical cream | Experimental | 120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream Receives: Drug: WR 279,396 topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final Clinical Cure Rate for the Index Lesion
Number of index lesions with 100% reepithelialization at Day 98.
Measured: Final clincial cure is measured at day 98
Secondary outcomes (4)
Area of Index Lesions Throughout the Study
Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Measured on day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: This study was closed prematurely due study team travel restrictions.
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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- Afif Ben Salah, M.D., Ph.D., Principal investigator, Institute Pasteur Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494350
- Sponsor's protocol ID
- S-10-0006; A-16898.3
- Status last verified
- Dec 2014
- First submitted
- 30 Nov 2011
- Last updated
- 19 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Treatment of Non-complicated, Non-severe, Cutaneous Leishmaniasis in Tunisia With WR 279,396 (Paromomycin + Gentamicin Topical Cream) )
- ClinicalTrials.gov ID
- NCT01494350
- Acronym / sponsor ID
- S-10-0006; A-16898.3
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- cutaneous leishmaniasis, topical treatment, Tunisia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed prematurely due study team travel restrictions.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Dec 2011 (estimated)
- Results
- Posted 19 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 topical cream | Experimental | Drug: WR 279,396 topical cream120 subjects will be enrolled to this open label study to receive WR 279,396 topical cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Subject has < 7 leishmaniasis total lesions.
- Subject is willing to forego other forms of treatments for CL including other investigational treatments during the study.
Key exclusion criteria (6 listed)
- 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.
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 279,396 topical creamAlso: WR 279, 396, Topical Paromomycin + Gentamicin CreamWR 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. | Drug | WR 279,396 topical cream |
Primary outcome
Final Clinical Cure Rate for the Index Lesion
Time frame: Final clincial cure is measured at day 98
Number of index lesions with 100% reepithelialization at Day 98.
4 secondary outcomes
Area of Index Lesions Throughout the Study
Time frame: Measured at day 0, 20, 28, 42, and 98
Number of Index Lesions With Reepithelialization Throughout the Study
Time frame: Measured at day 28 and 42
Area of All Ulcerated Lesions Throughout the Study
Time frame: Measured at day 20, 28, 42 and 98
Number of All Ulcerated Lesions With Reepithelialization on Day 28
Time frame: Measured on day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Afif Ben Salah, M.D., Ph.D. principal investigator
Institute Pasteur Tunisia
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 topical cream in people with Cutaneous Leishmaniasis, run by U.S. Army Medical Research and Development Command at 1 site in Tunisia.
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 6 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 19 Dec 2014. 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 Tunisia. 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 19 Dec 2014). 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?
Final Clinical Cure Rate for the Index Lesion (time frame: Final clincial cure is measured at day 98). 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 19 Dec 2014.