Actively Recruiting
Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
Led by Medecins Sans Frontieres, Netherlands · Updated on 2025-05-09
832
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
randomised control clinical trial to evaluate miltefosine, thermotherapy and the combination miltefosine-thermotherapy are effective, safe and tolerable alternative treatment options to treat cutaneous leishmaniasis caused by L. tropica, in Pakistan compared to the standard of care.
CONDITIONS
Official Title
Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients with clinical and laboratory confirmed cutaneous leishmaniasis who can be treated with localized intralesional antimonial injections and/or thermotherapy
- Lesion size between 0.5 cm and 4 cm
- Lesions not located on ear, nose, near eye, mucosal membranes, joints, or locations difficult for thermotherapy or injections
- Patients with 4 or fewer lesions
- Lesion duration less than five months by patient history
- Patients who have signed the informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Non-pregnant women of reproductive age not using effective contraception for five months
- Patients younger than 10 years old
- Patients with more than 4 lesions, lesions larger than 4 cm, or lesions on joints, lips, nose, ears, or near eyes
- History of significant medical problems or treatments affecting wound healing, such as diabetes, vascular diseases, or immunocompromising conditions
- Treatment for leishmaniasis within eight weeks before trial start
- Known or suspected hypersensitivity to trial medications or excipients
- Serum creatinine above normal or ALT three times above normal at screening
- Patients unwilling or unable to attend trial visits or comply with follow-up for three months
- Known history of drug addiction or alcohol abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Kuchlak Primary Health Care Centre (MCH)
Kuchlagh, Balochistan, Pakistan
Actively Recruiting
2
Shaheed Mohtarma Benazir Bhutto General Hospital
Quetta, Balochistan, Pakistan
Actively Recruiting
Research Team
S
Suzette Sabine Kämink
CONTACT
K
Koert Ritmeijer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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