Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis
ConditionCutaneous Leishmaniasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHayder Adnan Fawzi
About this trial
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.
Eligibility criteria
Qualifiers
Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis and patients ranging in age from 20 to 75 years old.
Disqualifiers
Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study and patients on prolonged corticosteroid therapy.
Trial design
Treatments tested in this trial
- Levofloxacin 0.5%
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Hayder Adnan Fawzi
Lead sponsor
Al-Mustafa University College
Sponsor institution
Source ClinicalTrials.gov