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WR 279,396 for the Treatment of Cutaneous Leishmaniasis (PAGELEC)

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ClinicalTrials.gov Identifier: NCT01988909
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : January 25, 2017
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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).

Condition or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: WR 279,396 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
Experimental: WR 279,396
All patients with the same Study drug: WR 279,396 (Topical Paromomycin and Gentamicin Cream)
Drug: WR 279,396
Paromomycin + Gentamicin Topical Cream

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. final clinical cure rate for the index lesion: Relapse [ Time Frame: day 42 or day 100 ]
    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

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

To be eligible for the study, patients must:

  1. Be male or females ages 2 to 80 years of age, inclusive.
  2. Have non-complicated, non-severe CL.
  3. Be able to give written informed consent or by their legal representative.
  4. 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.
  5. Have at least one ulcerative lesion ≥ 1 cm and < 5 cm, that meets the criteria for an index lesion.
  6. Be willing to forego other forms of treatments for CL including other investigational treatment during the study.
  7. In the opinion of the investigator, be capable of understanding (or their legal representative) and complying with the protocol.
  8. 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.
  9. 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.

Exclusion Criteria:

Also, to be eligible for the study, patients must not:

  1. Have a prior diagnosis of leishmaniasis where all lesions had healed.
  2. 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.
  3. Have a lesion due to leishmania that involves the mucosa or palate.
  4. Have signs and symptoms of disseminated disease.
  5. Be a female who is breast-feeding.
  6. 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.
  7. 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.
  8. 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.
  9. Have history of known or suspected hypersensitivity or idiosyncratic reactions to aminoglycosides.
  10. Have any other topical disease/condition which would interfere with the objectives of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988909

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Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Centre d'investigations cliniques- Hopital Robert Debré
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
U.S. Army Medical Research and Development Command
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Principal Investigator: Pierre Buffet, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01988909    
Other Study ID Numbers: P080705
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cutaneous leishmaniasis
Paromomycin + Gentamicin Topical Cream
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases