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NCT Number: NCT06798415

Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis

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

In an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. Each lesion will be 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 metronidazole (5 mg/ml, 100 ml, Flagyl®, 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 will be only asked to come for lesion assessment. A fine insulin needle will be used to infiltrate the lesion.

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Key information

Conditions

Cutaneous Leishmaniasis Euglenozoa Infections Infections Leishmaniasis Leishmaniasis, Cutaneous Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases Vector Borne Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mustansiriyah University

Baghdad, 10054, Iraq

Location status: Recruiting

Location contact

Kadhim Ali Kadhim, PhD

CONTACT

[email protected]

7700365655 ext. +964

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion criteria

  • Immunocompromised
  • Allergic reaction to treatment.

Treatment and study plan

Metronidazole

Drug

Intralesional metronidazole (5 mg/ml, 100 ml, Flagyl®, 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 will be added. The solutions will be injected intralesionally and not subcutaneously.

Primary outcomes

  1. Cure rate

    Time frame: From enrollment to the end of treatment up to 90 days.

    Patients were followed weekly up to 90 days after the first injection; four parameters were used for assessment as follows according to Sharquie modified leishmania score: 1. Measure the size of the lesion through the surface area 2. Measurement of the induration of the lesion 3. Assess the degree of erythema of the lesion 4. Assess the presence and absence of ulceration The obtained data is converted from numbers into scores. The total score was calculated by adding individual scores. Score 13-16: Mild response. Score 9-12: Moderate response. Score 5-8: Marked response. Score 0-4: Complete response & clearance Both marked and complete responses are considered as a cure

Study contacts

Contact information is provided by the study sponsor or research team.

Hayder Adnan Fawzi, PhD

CONTACT

[email protected]

07800106177 ext. + 964

Sponsors and collaborators

Lead sponsor

Hayder Adnan Fawzi

Other

Registry information

Official study title

The Clinical Effect of Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis: Single-arm Open-label Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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