A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
Condition: Old World Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: WR279,396 with Tegaderm Dressing; WR 279,396 with Gauze and Tape Dressing
Intervention description: Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing; Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ointment to treat leishmania skin lesions

Summary:

      This Phase 2 study is to determine whether WR279396 with occlusion (a polyurethane dressing)
      is more effective than WR279396 without occlusion for once daily treatment.

      Extensive objective and subjective local tolerance data will also be captured during this
      trial, as well as surrogate markers (parasite loads and aminoglycosides concentration in the
      deep dermis) that may help to determine the optimal number and duration of treatments.

      The results from this study will help determine the most practical treatment schedule and
      will answer questions that are crucial to improve the present treatment regimen with WR279396
      which is twice a day for 20 days.
    

Eligibility criteria:

        Inclusion Criteria: The study population will be selected from adults (18y) patients and
        children above 15y in Tunisia (Old World)

          -  Age: 15 - 75 years old

          -  Lesion character: each diameter (horizontal and vertical) of the lesion test must
             measure 7 mm, the lesion must be primarily ulcerative (i.e., not verrucous or nodular)
             and located in a biopsy friendly site of the body

          -  Parasitological diagnosis: have cutaneous leishmaniasis proven parasitologically in
             lesion selected for inclusion in study (lesion test).

          -  Informed consent: have given written informed consent to participate in the study:
             (i.e. patient or legal representative).

        Exclusion Criteria:

          -  Drug intolerance: history of known or suspected hypersensitivity or idiosyncratic
             reactions to aminoglycosides in the patient or immediate family members.

          -  Previous use of antileishmanial drugs (within 2 months) or present use of routinely
             nephrotoxic or ototoxic drugs.

          -  Potential for follow up: Have less than 4 months time remaining in present address
             and/or plans to leave the area for more than 30 days.

          -  Extent of disease: More than 10 lesions or lesion ³ 5 cm or a lesion less than 2 cm
             from eye, in the ear, or a lesion in the face, that in the opinion of the attending
             dermatologist could potentially cause significant disfigurement.

          -  Location of disease: mucosal involvement.

          -  Disseminated disease: clinically significant lymphadenitis with nodules that are
             painful and > 1 cm in size in the lymphatic drainage of the ulcer.

          -  Concomitant medical problems: significant medical problems of the kidney or liver as
             determined by history and by the following laboratory studies:

          -  Kidney: clinically significant abnormalities of urine analysis, serum levels of
             Creatinine, BUN, total proteins > upper limit of normal for the laboratory.

          -  Liver: AST or ALT > upper limit of normal for the laboratory.

          -  General: glucose, Na, K, > upper limit of normal or < lower limit of normal for the
             laboratory. Volunteers in whom these normal laboratory values are exceeded by less
             than 25% will not be automatically excluded. These volunteers will be evaluated on the
             basis of history, physical, as well as laboratory values.

          -  Scheduled or ongoing pregnancy as determined clinical and biological criteria.

          -  Presence of signs or symptoms of peripheral neuropathy, myasthenia gravis or
             neuromuscular block