Complex Cutaneous Leishmaniasis Healing Study in Algeria
Complex Cutaneous Leishmaniasis Healing Study in Algeria
This study evaluates the effect of clean wound management and dressing on complex zoonotic
 cutaneous leishmaniasis caused by L. major in the MENA region (Algeria). The patients will
 participate in the wound dressing themselves. The objective is to determine the amount of
 patients that can avoid systemic chemotherapy with pentavalent antimony which is compulsory
 for patients with complex CL lesions. In Algeria, this requires expensive hospital care
 because of the eventual toxic side effects of Sb(V).
The investigator initiated, non-interventional LeiClean Trial with 100 CL patients presenting
 complex CL lesions, normally in need of a systemic an in-door treatment with meglumine
 antimoniate and in risk of systemic antimony toxicity (see inclusion criteria!) during the CL
 season of 2017/18 is part of the renewed cooperation treaty between the IPA and WM e. V. and
 originates from encouraging compassionate use observations after topical LeiClean treatment
 authorized by the Algerian Ministry of Health in December 2015. The study will be carried out
 in the ZCL region of M'Sila and Bou Saada.

 The German Regulation Authority, BfArM, has granted a special approval according to §11 MPG
 (German regulation for Medical Devices) to the new filmogenic gel dressing LeiProtect®. The
 patients with complex cutaneous leishmaniasis (Giemsa and PCR confirmed) elected for indoor
 treatment with systemic antimony treatment are given the option for a LeiClean treatment of
 their lesions; they are instructed on hand hygiene and LeiProtect® dressing of their lesions
 which they carry out themselves at home during seven days. On day eight they come for lesion
 cleansing and photographic monitoring before they start another weekly LeiClean cycle. The
 patients can at any time opt for a conventional systemic chemotherapeutic treatment in a
 hospital if they are not satisfied with their healing progress. However, if the doctor
 realizes that after two months the hygienic wound management results in inadequate healing,
 he can also order hospital for the patients. The doctor will allow the patients to visualise
 their healing progress over the course of the trial through digital images on the computer.

 After complete epithelisation of the lesions, the patients come for controls at monthly
 intervals up to a period of five months to check for eventual lesion relapses. The costs of
 the LeiClean outdoor treatment will be evaluated and compared to the already known hospital
 costs per patient for a three-week systemic indoor Sb(V) treatment.
Inclusion Criteria:

 -  Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis

 -  Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility

 -  Subject gives voluntary consent

 Exclusion Criteria:

 -  Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)