Cutaneous LeishmaniasisPhase 2PAGELECNCT01988909
WR 279,396 for the Treatment of Cutaneous Leishmaniasis
A Phase 2 study testing WR 279,396 in people with Cutaneous Leishmaniasis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin \& gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL). Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Cutaneous Leishmaniasis
- What is being tested?
- WR 279,396
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2013to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for the study, patients must:
- Be male or females ages 2 to 80 years of age, inclusive.
- Have non-complicated, non-severe CL.
- Be able to give written informed consent or by their legal representative.
- 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 and/or 3) by positive polymerase chain reaction (PCR). Patients who have a prior diagnosis of CL within 30 days of the start of treatment are eligible without a confirmatory test during screening.
- Have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion.
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- Be willing to forego other forms of treatments for CL including other investigational treatment during the study.
- In the opinion of the investigator, be capable of understanding (or their legal representative) and complying with the protocol.
- Expect to be located in the area of the clinical site for at least the duration of the screening, 20-day treatment period, and for the followup visits at Days 28 +/- 2 days, 42 +/- 7 days and 100 +/- 14 days.
- If female and of child-bearing potential, have a negative serum or urine 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.
Who cannot join
- Also, to be eligible for the study, patients must not:
- Have a prior diagnosis of leishmaniasis where all lesions had healed.
- Have 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.
- Have a lesion due to leishmania that involves the mucosa or palate.
- Have signs and symptoms of disseminated disease.
- Be a female who is breast-feeding.
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- Have 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.
- Have significant organ abnormality, chronic disease such as diabetes, severe hearing loss, evidence of renal or hepatic dysfunction, myasthenia gravis, parkinsonism, impairment of the eighth cranial nerve or clinically significant levels of creatinine, AST, or ALT in the judgment of the investigator.
- Have received treatment for leishmaniasis (except mercurochrome or local antiseptics) including 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) within 56 days of starting study treatments, or methylbenzethonium chloride (MBCL); or local or systemic antibiotics of the following families (penicillin, betalactamics, cyclines, synergistin, macrolides, lincosamides, fusidic acid, mupirocin) within 8 days of starting study treatments.
- Have history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
- Have any other topical disease/condition which would interfere with the objectives of this study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
Centre d'investigations cliniques- Hopital Robert Debré
Paris, 75019
About this study
Official title: An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France
The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin \& gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).
Read the detailed description
Patients with suspected CL will be screened up to a 14 day period for eligibility including parasitology for confirmation of ulcerative CL. Recruitment will primarily be from patients exposed to leishmaniasis. A target enrollment of 30 patients will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) once daily for 20 days.
The index lesion and all other ulcerated lesions will be assessed for clinical response by measurement of the length and width of area of ulceration. A lesion will be considered to be completely cured if 100% re-epithelialization is observed. Non-ulcerated lesions will also be measured to monitor the total area of exposure of lesions to study drug and will be evaluated for cure.
- Conditions
- Cutaneous Leishmaniasis
- Being tested
- WR 279,396
- Keywords
- Cutaneous leishmaniasis, Paromomycin + Gentamicin Topical Cream, Safety, Efficacy
- 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 279,396Drug
Paromomycin + Gentamicin Topical Cream
| Study group | Role | What they receive |
|---|---|---|
| WR 279,396 | Experimental | All patients with the same Study drug: WR 279,396 (Topical Paromomycin and Gentamicin Cream) Receives: Drug: WR 279,396 |
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: initial clinical cure
Initial clinical cure: 100% reepithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed >50% reepithelialization by Day 100
Measured: Day 42 or day 100
Secondary outcomes (1)
final clinical cure rate for the index lesion: Relapse
Relapse is defined as a 10 percent or greater increase in the area of ulceration of the index lesion or a shift from 100% to < 100% re-epithelialization of the index lesion at nominal Day 100 for those patients that had 100% re-epithelialization of the index lesion at nominal Day 42 or before
Measured: day 42 or day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Pierre Buffet, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988909
- Sponsor's protocol ID
- P080705
- Acronym
- PAGELEC
- Status last verified
- Jan 2017
- First submitted
- 14 Nov 2013
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France
- ClinicalTrials.gov ID
- NCT01988909
- Acronym / sponsor ID
- PAGELEC / P080705
- Conditions
- Cutaneous Leishmaniasis
- Keywords
- Cutaneous leishmaniasis, Paromomycin + Gentamicin Topical Cream, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
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 and efficacy of open label treatment with WR 279,396 (topical paromomycin \& gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).
Detailed description
Patients with suspected CL will be screened up to a 14 day period for eligibility including parasitology for confirmation of ulcerative CL. Recruitment will primarily be from patients exposed to leishmaniasis. A target enrollment of 30 patients will receive WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream) once daily for 20 days.
The index lesion and all other ulcerated lesions will be assessed for clinical response by measurement of the length and width of area of ulceration. A lesion will be considered to be completely cured if 100% re-epithelialization is observed. Non-ulcerated lesions will also be measured to monitor the total area of exposure of lesions to study drug and will be evaluated for cure.
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 patients with the same Study drug: WR 279,396 (Topical Paromomycin and Gentamicin Cream) |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Be male or females ages 2 to 80 years of age, inclusive.
- Have non-complicated, non-severe CL.
- Be able to give written informed consent or by their legal representative.
- 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 and/or 3) by positive polymerase chain reaction (PCR). Patients who have a prior diagnosis of CL within 30 days of the start of treatment are eligible without a confirmatory test during screening.
- Have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion.
Key exclusion criteria (11 listed)
- Have a prior diagnosis of leishmaniasis where all lesions had healed.
- Have 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.
- Have a lesion due to leishmania that involves the mucosa or palate.
- Have signs and symptoms of disseminated disease.
- Be 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 279,396Paromomycin + Gentamicin Topical Cream | Drug | WR 279,396 |
Primary outcome
final clinical cure rate for the index lesion: initial clinical cure
Time frame: Day 42 or day 100
Initial clinical cure: 100% reepithelialization (ie, a 0 x 0 length x width measurement) of the lesion at the nominal Day 42 evaluation, or initial clinical improvement followed >50% reepithelialization by Day 100
1 secondary outcome
final clinical cure rate for the index lesion: Relapse
Time frame: day 42 or day 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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.
Pierre Buffet, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites 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 Cutaneous Leishmaniasis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 10 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: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: initial clinical cure (time frame: Day 42 or day 100). 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 25 Jan 2017.