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

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.

Study Overview

• Status: Recruiting
• Conditions: Cutaneous Leishmaniasis
• Intervention / Treatment: Drug: Ciprofloxacin (BAYO9867); Drug: sodium stibogluconate (Pentostam)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hayder Adnan Fawzi, PhD; Phone Number: + 964 009647800106177; Email: haider-pharm@almustafauniversity.edu.iq

Study Locations

• Iraq
  • Baghdad, Iraq, 10047
    • Recruiting
    • Mustansiriyah University
    • Contact: Kadhim Ali Kadhim, PhD; Phone Number: +964 7700365655; Email: Pharm.drkaka75@uomustansiriyah.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intralesional ciprofloxacin; Intralesional ciprofloxacin (2 mg/ml, 100 ml, Ciproxin®, Bayer Schering pharma AG, Germany), each lesion was injected based on lesion size (2 mg/cm2). The infiltration of intralesional dose was 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 was used to infiltrate the lesion. The lesion was thoroughly infiltrated with the drug solution until the base was 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 was added. The solutions were injected intralesionally and not subcutaneously.	Drug: Ciprofloxacin (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).
Active Comparator: intralesional sodium stibogluconate; Intralesional sodium stibogluconate (100 mg/ml, 100 ml vial, Pentostam®, GlaxoSmithKline, UK), each lesion was injected based on lesion size (1 mg/cm2). The infiltration of intralesional dose was 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 was used to infiltrate the lesion. The lesion was thoroughly infiltrated with the drug solution until the base was 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 was added. The solutions were injected intralesionally and not subcutaneously.	Drug: sodium 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate	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	From enrollment to the end of treatment up to 90 days.

Collaborators and Investigators

• Sponsor: Al-Mustafa University College
• Collaborators: Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Infections; Protozoan Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Parasitic; Euglenozoa Infections; Skin and Connective Tissue Diseases; Leishmaniasis; Leishmaniasis, Cutaneous; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Gluconates; Ciprofloxacin; Antimony Sodium Gluconate
• Other Study ID Numbers: ALM25-002; apporval no (58) (Other Identifier: Research Ethical Approval of Mustansiriyah University/ College of Pharmacy)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No