Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: A Phase 2 Study in the Old World
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: WR 279,396; Placebo
Intervention description: A topical cream containing 15% paromomycin and 0.5% gentamicin. Approximately 0.0005 mL per mm2 of skin lesion; Topical cream vehicle. Approximately 0.0005 mL per mm2 of skin lesion
Intervention MeSH terms: Paromomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 92.0
Sex: All
Minimum age: 5 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: cutaneous leishmaniasis topical treatment safety efficacy

Summary:

      This study is to determine the effectiveness and safety of WR 279,396, a topical cream for
      the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo
      control under double-blind conditions in a local population group in Tunisia where
      leishmaniasis is endemic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 5-75 years

          -  Lesions must measure at least 1 cm and be primarily ulcerative

          -  Have cutaneous leishmaniasis proven parasitologically in the lesion selected for study

          -  Must have given written informed consent to participate in the study

        Exclusion Criteria:

          -  Known drug intolerance to aminoglycosides in the patient or immediate family

          -  Previous use of antileishmanial drugs (within 3 months) or present use of routinely
             nephrotoxic or ototoxic drugs

          -  Patients with tuberculosis under treatment

          -  Potential for follow-up: have less than 7 months time remaining in present address
             and/or plan to leave the area for more than 30 days

          -  Extent of disease: more than 5 lesions or lesion equal to or greater than 5 cm or a
             lesion less than 5 cm from the eye, 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 greater than 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:

          -  Hearing abnormality

          -  Ongoing pregnancy or have plans to become pregnant

          -  Females of child bearing age (Tunisia Only)

          -  Signs or symptoms of peripheral neuropathy

        Kidney: clinically significant abnormalities of urine analysis, serum levels of creatinine,
        BUN, total proteins greater than the upper limit of normal for the laboratory.

        Liver: AST or ALT greater than the upper limit of normal for the laboratory General:
        glucose, Na+, or K+ greater than the upper limit of normal for the laboratory