Actively Recruiting
Effectiveness of Ciprofloxacin Intralesional Injection Compared to Sodium Stibogluconate in Treating Cutaneous Leishmaniasis: A Randomized Parallel Groups Trial
Led by Al-Mustafa University College · Updated on 2025-09-30
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Al-Mustafa University College
Lead Sponsor
A
Al-Mustansiriyah University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of intralesional ciprofloxacin 0.2% solution compared to intralesional sodium stibogluconate (SSG) 10% intravenous solution for treating cutaneous leishmaniasis. This phase 2 randomized parallel groups clinical trial aims to compare these two local injection therapies for patients with cutaneous leishmaniasis lesions. Participants are divided into two groups receiving either weekly intralesional injections of ciprofloxacin at a dose of 2 mg/cm2 or sodium stibogluconate at 1 mg/cm2. Both treatments are given once weekly for up to six weeks. Each lesion is injected using a fine insulin needle until the base is blanched, with volumes ranging from 0.2 to 4.0 ml per lesion depending on size. Treatment stops early if lesions are cured before six weeks. During the study, each lesion is followed for up to 90 days or until it is cured. Patients attend weekly visits for injections and lesion assessments. Researchers measure the cure rate from enrollment to the end of treatment within the 90-day follow-up. Safety and response are closely monitored throughout the study period.
CONDITIONS
Brief Title
Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with single or multiple (less than seven) lesions of cutaneous leishmaniasis
- Age between 18 and 80 years
You will not qualify if you...
- Patients who received any anti-leishmaniasis treatment locally or systemically in the last month
- Patients on prolonged corticosteroid therapy
- Patients with seven or more cutaneous leishmaniasis lesions
- Patients outside the age range of 18 to 80 years if applicable based on study enrollment criteria (implied exclusion if outside age range)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 weeks
Participants receive weekly intralesional injections of either ciprofloxacin or sodium stibogluconate to treat cutaneous leishmaniasis. Treatment lasts up to 6 weeks but may stop earlier if the participant is cured.
Weekly visits for up to 6 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Mustansiriyah University
Baghdad, Iraq, 10047
Actively Recruiting
Research Team
H
Hayder Adnan Fawzi, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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