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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 30, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary and study completion dates: May 1, 2025 to Nov 1, 2025v3
  2. Minor Start date changed from estimate of Jan 20, 2025 to Feb 7, 2025v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06798402
Lead Sponsor Al-Mustafa University College
Collaborators: Al-Mustansiriyah University
Conditions
(from sponsor)
Cutaneous Leishmaniasis
Related terms Leishmaniasis, Cutaneous
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov