Using levofloxacin injections to treat skin leishmaniasis
The Clinical Effect of Intralesional Injection of Levofloxacin for the Management of Cutaneous Leishmaniasis: Single Arm Open-label Trial
This study is testing if weekly injections of levofloxacin can effectively treat skin leishmaniasis in patients with localized lesions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Al-Mustafa University College Academic / other |
| Locations | 1 site (Baghdad) |
| Trial ID | NCT06797544 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intralesional levofloxacin 0.5% solution as a local injection for treating cutaneous leishmaniasis. In an open-label single-arm design, patients with cutaneous leishmaniasis lesions receive weekly injections of levofloxacin for up to six weeks, with follow-up for 90 days or until lesions are cured. The study aims to provide a safer and more cost-effective alternative to traditional systemic therapies for patients with localized forms of the disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 with one to six lesions of cutaneous leishmaniasis.
Not a fit: Patients who have received anti-leishmaniasis treatment in the past month or are on prolonged corticosteroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective local option for patients suffering from cutaneous leishmaniasis.
How similar studies have performed: While local therapies for cutaneous leishmaniasis have been recommended, the specific use of intralesional levofloxacin is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baghdad
- Mustansiriyah University — Baghdad, Iraq (Recruiting)
Study contacts
- Study coordinator: Hayder Adnan Fawzi, PhD
- Email: haider-pharm@almustafauniversity.edu.iq
- Phone: 07800106177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.