RecruitingPhase 2NCT06798402

Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate

Effectiveness of Ciprofloxacin Intralesional Injection in the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate: a Parallel Groups Comparative Trial


Sponsor

Al-Mustafa University College

Enrollment

80 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection. In a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria1

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

Exclusion Criteria2

  • Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study
  • patients on prolonged corticosteroid therapy.

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Interventions

DRUGCiprofloxacin (BAYO9867)

Intralesional ciprofloxacin (2 mg/ml, 100 ml, Ciproxin®, Bayer Schering pharma AG, Germany), each lesion was injected based on lesion size (2 mg/cm2).

DRUGsodium stibogluconate (Pentostam)

Intralesional sodium stibogluconate (100 mg/ml, 100 ml vial, Pentostam®, GlaxoSmithKline, UK), each lesion was injected based on lesion size (1 mg/cm2)


Locations(1)

Mustansiriyah University

Baghdad, Iraq

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NCT06798402


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