Using metronidazole injections to treat skin lesions from leishmaniasis
The Clinical Effect of Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis: Single-arm Open-label Trial
This study is testing if weekly injections of metronidazole can help people with skin lesions from leishmaniasis heal faster.
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 | NCT06798415 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intralesional metronidazole 0.5% solution as a treatment for cutaneous leishmaniasis. In an open-label, single-arm design, patients with one or more lesions will receive weekly injections of metronidazole directly into the lesions for up to six weeks. Each lesion will be monitored for a period of 90 days or until it is cured, with the treatment being stopped if a lesion heals before the six-week mark. The study aims to determine the local efficacy of this intervention in managing the condition.
Who should consider this trial
Good fit: Ideal candidates are patients with one to six lesions of cutaneous leishmaniasis who are not immunocompromised.
Not a fit: Patients who are immunocompromised or have a known allergy to metronidazole will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and localized option for patients suffering from cutaneous leishmaniasis.
How similar studies have performed: While this approach is novel for cutaneous leishmaniasis, similar intralesional treatments have shown promise in other dermatological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis Exclusion Criteria: * Immunocompromised * Allergic reaction to treatment.
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.