Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate
NCT ID: NCT06798402
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-02-07
2025-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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).
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.
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)
Interventions
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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).
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)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients on prolonged corticosteroid therapy.
18 Years
80 Years
ALL
No
Sponsors
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Al-Mustansiriyah University
OTHER
Al-Mustafa University College
OTHER
Responsible Party
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Hayder Adnan Fawzi
Ass Prof
Locations
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Mustansiriyah University
Baghdad, , Iraq
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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apporval no (58)
Identifier Type: OTHER
Identifier Source: secondary_id
ALM25-002
Identifier Type: -
Identifier Source: org_study_id
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