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

NCT06798402 | Recruiting Phase 2 DMC

• 2 other identifiers: ALM25-002apporval no (58)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Leishmaniasis

Outcome Measures

Primary Outcomes (1)

• 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: 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

  From enrollment to the end of treatment up to 90 days.

Study Arms (2)

intralesional ciprofloxacin

EXPERIMENTAL

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 sodium stibogluconate

ACTIVE COMPARATOR

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)

Interventions

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).

intralesional ciprofloxacin

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)

intralesional sodium stibogluconate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Mustafa University College: lead
• Al-Mustansiriyah University: collaborator

Study Sites (1)

Mustansiriyah University

Baghdad, 10047, Iraq

RECRUITING

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Ciprofloxacin; Antimony Sodium Gluconate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Organic Chemicals; Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Central Study Contacts

Hayder Adnan Fawzi, PhD

CONTACT

009647800106177; haider-pharm@almustafauniversity.edu.iq

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Prof

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 29, 2025
• Study Start: February 7, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

IR (1)