Phase 3 Study of Walter Reed (WR) 279,396 and Paromomycin Alone for the Treatment of Cutaneous Leishmaniasis in Panama
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: WR 279,396; Paromomycin
Intervention description: WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%; Paromomycin alone
Intervention MeSH terms: Gentamicins; Paromomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 399.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: leishmaniasis; cutaneous leishmaniasis; Leishmania panamensis; L panamensis; Paromomycin; Paromomycin/Gentamicin

Summary:

      This study is a pivotal Phase 3, randomized, double-blind, 3-site, two-group trial assessing
      the efficacy and safety of WR 279,396 Topical Cream and Paromomycin Alone Topical Cream in
      subjects with CL in Panama. The primary objective of this study is to determine if WR 279,396
      results in statistically superior final clinical cure rates of an index lesion when compared
      with Paromomycin Alone for the treatment of CL in Panama expected to be caused by L
      panamensis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 2 years-of-age

          -  Subject or legal guardian able to give written informed consent or assent, as
             appropriate

          -  Diagnosis of CL in at least one lesion by at least one of the following methods: 1)
             positive culture for promastigotes or 2) microscopic identification of amastigotes in
             stained lesion tissue

          -  At least one ulcerative lesion ≥ 1 cm and ≤ 5 cm that has a diagnosis of CL

          -  Willing to forego other forms of treatments for CL including other investigational
             treatments during the study

          -  In the opinion of the investigator, subject (or their legal guardian), subject is
             capable of understanding and complying with the protocol

          -  If female and of child-bearing potential, must have a negative serum pregnancy test
             during screening and agree to use an acceptable method of birth control during the
             treatment phase and for 1 week after treatment is completed

        Exclusion Criteria:

          -  Lesion due to leishmania that involves the nasal or oral mucosa or any signs of
             mucosal disease that might be due to Leishmania

          -  Only a single lesion on the ear with erosive cartilage

          -  Signs and symptoms of disseminated disease in the opinion of the investigator

          -  More than 10 lesions

          -  Female who is breast-feeding

          -  Significant organ abnormality, chronic disease such as diabetes, severe hearing loss,
             evidence of renal or hepatic dysfunction, or creatinine, aspartate aminotransferase
             (AST), or alanine aminotransferase (ALT) greater than 15% above the upper limit of
             normal (ULN) as defined by the clinical laboratory defined normal ranges

          -  Received treatment for leishmaniasis including any medication with pentavalent
             antimony including sodium stibogluconate (Pentostam™), meglumine antimoniate
             (Glucantime™); amphotericin B (including liposomal amphotericin B and amphotericin B
             deoxycholate); or other medications containing paromomycin (administered parenterally
             or topically) or methylbenzethonium chloride (MBCL); gentamicin; fluconazole;
             ketoconazole; pentamidine; miltefosine, azithromycin or allopurinol that was completed
             within 56 days of starting study treatments

          -  History of known or suspected hypersensitivity or idiosyncratic reactions to
             aminoglycosides