Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

Hayder Adnan Fawzi

Status and phase: Enrolling; Phase 2

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Levofloxacin 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT06797544

apporval no (57) (Other Identifier)

ALM25-001

Details and patient eligibility

About

Aim of the study to evaluate the effectiveness of intralesional levofloxacin 0.5% solution as a local injection in treating cutaneous leishmaniasis.

In an open-label single-arm clinical trial, all patients were given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.

Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment. A fine insulin needle will be used to infiltrate the lesion.

Full description

Local therapies have been recommended by the World Health Organization (WHO), the Pan American Health Organization, and other experts as an alternative to systemic drugs in patients with at least four lesions smaller than 4 cm in diameter, especially when the face or joints are not affected. Usually, they are easy to use and have a lower risk, toxicity, and cost compared to traditional therapies. Local treatment includes thermotherapy, cryotherapy, and topical and intralesional drugs. The last approach is effective and safe in localized forms

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis and patients ranging in age from 20 to 75 years old.

Exclusion criteria

• Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study and patients on prolonged corticosteroid therapy.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Intralesional levofloxacin

Experimental group

Description:

Intralesional levofloxacin (5 mg/ml, 100 ml, Tavanic®, Sanofi, France) will be injected into each lesion based on its size (5 mg/cm2). The infiltration of intralesional dose will be given once weekly for up to 6 weeks. Treatment will be stopped in patients cured before 6 weeks of treatment, and patients were only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.

Treatment:

Drug: Levofloxacin 0.5%