Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06798402

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

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.

Recruiting

Interested in participating?

Request Info

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, 10047, 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

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

Treatment and study plan

Ciprofloxacin (BAYO9867)

Drug

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

Sodium stibogluconate (Pentostam)

Drug

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

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:

    • Measure the size of the lesion through the surface area
    • Measurement of the induration of the lesion
    • Assess the degree of erythema of the lesion
    • 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]

009647800106177 ext. + 964

Sponsors and collaborators

Lead sponsor

Al-Mustafa University College

Other

Collaborators

  • Al-Mustansiriyah University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Sep 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.