Paromomycin for Individuals With Uncomplicated Cutaneous Leishmaniasis

Leishmaniasis, Cutaneous Clinical Trial

Official title: Paromomycin Topical Cream Treatment Protocol for Individuals With Uncomplicated Cutaneous Leishmaniasis

Status No longer available

Clinical Trial Summary

This is an expanded access treatment protocol designed to provide a topical cream treatment option to military health care beneficiaries with parasitologically confirmed uncomplicated Cutaneous Leishmaniasis.

Clinical Trial Description

When a military health care beneficiary presents at a Department of Defense Military Treatment Facility with a skin lesion clinically and epidemiologically consistent with suspicious Cutaneous Leishmaniasis (CL), routine diagnostic parasitology testing will be performed as standard of care, and if there is a positive diagnosis, the patient will be offered the option to participate in this treatment program and after providing written informed consent/assent., if eligible to participate, the patient will receive treatment with Paromomycin Topical Cream.

Eligible patients will receive Paromomycin Topical Cream applied topically to all CL lesions once daily for 20 days. The Day 1 application will be performed by or under the supervision of the site PI. The Day 2 application will be performed by the patient while being observed by the site PI or a designated medical staff member. The patient will be scheduled to return to an Medical Treatment Facility (MTF) weekly during treatment at Days 7 ± 2, 14 ± 2, and Day 20 + 4 days (the last day of treatment). During these visits, a member of the medical team will observe the application of the cream by the patient and will assist the patient, if necessary. In addition, the patient will be scheduled to return for a safety evaluation approximately 1 week after completing treatment. The patient will be instructed to contact the site PI or designee if any unusual adverse events (AEs) occur during treatment or in the week after completing treatment. The patient will be scheduled to return to the MTF on Day 90 (± 14 days) days after starting treatment to determine whether all CL lesions have healed (as per CL standard of care). Those patients who cannot return to an MTF will be contacted by phone.

If at any time after completing treatment the lesions get worse or appear to be infected, the patient will be instructed to go to an MTF for possible treatment of AEs or alternative treatments for CL. ;

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

• NCT number: NCT01641796
• Study type: Expanded Access
• Source: U.S. Army Medical Research and Development Command
• Status: No longer available