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New treatment option for Old World Cutaneous Leishmaniasis
Official title Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
ClinicalTrials.gov ID: NCT04268524
What this study is testing
What is drug: miltefosine with thermotherapy?
drug: miltefosine with thermotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for old world cutaneous leishmaniasis.
Also referred to as device ThermoMed 1.8.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 and older
You may be able to join if
- Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and/or...
- lesion size ≥0.5 cm and ≤4 cm
- not located on the ear, nose, near to the eye or mucosal membranes, on joints, or on a location that in the opinion of the principle investigator...
- patient with ≤4 lesions
- duration of lesions less than five months by patient history
You likely can't join if
- Pregnant women and breast feeding women
- Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months
- Patients \<10years old
- Patients who cannot be treated with localised IL antimonial injections or TT (patients with more than 4 lesions, lesions \>4cm in diameter, or...
- History of clinically significant medical problems or treatment that might interact with the study treatment and interact with wound healing, such as...
- Within eight weeks of trial D1 received treatment for leishmaniasis with any medication
See the full eligibility criteria
- Male and female patients with clinical and laboratory confirmed CL, and who can be treated with localised intralesional antimonial injections and/or thermotherapy:
- lesion size ≥0.5 cm and ≤4 cm
- not located on the ear, nose, near to the eye or mucosal membranes, on joints, or on a location that in the opinion of the principle investigator (PI) is difficult to apply thermotherapy (TT) or intralesional (IL)...
- patient with ≤4 lesions
- duration of lesions less than five months by patient history
- Patients who have signed the informed consent form.
- Pregnant women and breast feeding women
- Non-pregnant women in reproductive age refusing effective (injectable) contraception for a period of five months
- Patients \<10years old
- Patients who cannot be treated with localised IL antimonial injections or TT (patients with more than 4 lesions, lesions \>4cm in diameter, or located on joints, lips, nose, ears or near eyes)
- History of clinically significant medical problems or treatment that might interact with the study treatment and interact with wound healing, such as diabetes, vascular diseases and any immunocompromising condition
- Within eight weeks of trial D1 received treatment for leishmaniasis with any medication
- History of known or suspected hypersensitivity of idiosyncratic reactions to trial medication or excipients
- Has laboratory values at screening: serum creatinine above normal level; ALT 3 times above normal range
- Patient who is not willing to attend the trial visits, or is not able to comply with follow-up visits up to three months.
- Known history of drug addiction and/or alcohol abuse
The study team makes the final eligibility decision.
Where it's taking place
- Kuchlagh, Balochistan, Pakistan
- Quetta, Balochistan, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kuchlagh, Balochistan, Pakistan; Quetta, Balochistan, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.