Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis

NCT ID: NCT06797544

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-09
• Study Completion Date: 2025-11-01

Brief Summary

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.

Detailed 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

Conditions

Cutaneous Leishmaniasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intralesional levofloxacin

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.

Group Type: EXPERIMENTAL

Levofloxacin 0.5%

Intervention Type: DRUG

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.

The lesion will be thoroughly infiltrated with the drug solution until the base will be completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia was added. The solutions were injected intralesionally and not subcutaneously.

Interventions

Levofloxacin 0.5%

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.

The lesion will be thoroughly infiltrated with the drug solution until the base will be completely blanched. Depending on the lesion size, the amount of solution required ranged from 0.2 to 4.0 ml per lesion. No local anesthesia was added. The solutions were injected intralesionally and not subcutaneously.

Intervention Type: DRUG

Other Intervention Names

Tavanic

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hayder Adnan Fawzi

OTHER

Sponsor Role: lead

Responsible Party

Hayder Adnan Fawzi

Ass Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mustansiriyah University

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Hayder Adnan Fawzi, PhD

Role: CONTACT

haider-pharm@almustafauniversity.edu.iq

07800106177 ext. + 964

Facility Contacts

Kadhim Ali Kadhim, PhD

Role: primary

Pharm.drkaka75@uomustansiriyah.edu.iq

7700365655 ext. +964

Other Identifiers

apporval no (57)

Identifier Type: OTHER

Identifier Source: secondary_id

ALM25-001

Identifier Type: -

Identifier Source: org_study_id