Old World Cutaneous Leishmaniasis Clinical Trial
Official title:
Randomised, Open Label, Multicentre, Non-inferiority Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan
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.
Until now, there is no well-established evidence based option to treat CL caused by the
Leishmania tropica, besides antimonial injections. Alternative treatment options are not
available in Pakistan, or there is limited evidence of the effectivity.
Effectiveness of thermotherapy in L. tropica is studied in only three studies in OWCL with a
variable cure rate (54.1% - 98%). But it could be an attractive option, because only one
treatment session is required and studies report less scarring tissue. Another promising
treatment option is oral miltefosine. There is considerable evidence in the literature of the
efficacy of miltefosine in treatment of CL caused by L. major, however no studies have been
conducted to evaluate the efficacy in CL caused by L. tropica species. This oral treatment
could have major benefits for CL patients as it can be provided in peripheral health
facilities and to patients who have contraindications to antimony treatment (elderly, and
patients with cardiac or renal disease, or diabetes). A combination of thermotherapy and
miltefosine, the advantages offered by this combination are that a) the use of a topical plus
a systemic treatment would hypothetically have an additive effect of two treatments with
different modes of action. For the reason that systemic treatment could eliminate those
circulating or remaining parasites located in the periphery of the lesion that topical
treatment fails to remove, which might be the cause of a relapse, b) it may reduce the
necessary length of treatment with miltefosine. For these above reasons, in a prospective
trial we aim to evaluate the effectiveness and safety of thermotherapy, miltefosine and the
combination of thermotherapy and miltefosine in CL caused by L. tropica, with the objective
to find a treatment with an efficacy which is non-inferior to the standard of care with
antimony injections.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01536795 -
A Study to Evaluate the Efficacy and Tolerance of WR279,396 for Old World Cutaneous Leishmaniasis
|
Phase 2 |