On August 30th, 2017, the German Regulatory Drug and Medical Device Agency, BfArM, has granted a special approval, i.e. a temporary market access for the wound healing device LeiProtect®, developed by our NGO, Waisenmedizin e.V., to treat wounds of neglected tropical skin diseases. In contrast to the usual injections with pentavalent antimony into the rim of cutaneous leishmaniasis ulcers, LeiProtect® lesion dressings are absolutely painless and, in a pilot-trial, could heal 45 complex CL lesions from 34 patients infected with L. major in Algeria without using systemic Sb(V) chemotherapy. With its anti-biofilm heme-activated pro-oxidant, sodium chlorosum for pharmaceutical use, the filmogenic gel substitutes the missing physical barrier of the skin and promotes healing of the skin lesion.
On July 23rd, 2018, we have obtained a second prolongation of the temporary license of LeiProtect® till September 2020 from BfArM in order to be able to include also complex NTD face lesions due to infection with L. tropica, which is not found in Algeria..
We have meanwhile asked the BfArM for a prolongation of the temporary license of LeiProtect® in order to be able to include also complex NTD face lesions due to infection with L. tropica, which is not found in Algeria.
With these 60 kg of filmogenic wound dressing gel we can treat several thousand patients with NTD skin lesions. For each patient to be treated we need 10 € including the costs for the GMP LeiProtect® production in Germany and for the gel transport abroad. Since L. major and L. tropica are the most common parasite species causing CL lesions in the Old World, we should monitor at least another 150 patients in a clinical trial whose lesions were caused by L. tropica, which will cost approximately €50,000.
Fifteen years of medical aid towards neglected diseases in Afghanistan have given us a distinctive competence in this domain and has created a network of trustworthy partners on-site for medical help in leishmania endemic countries. The NNN Skin Cross Cutting Group, which our NGO joined in March 2019 at the WHO Buruli Ulcer Conference in March 2019, will further facilitate our wound hygiene efforts in the treatment of the neglected tropical skin disease of leishmaniasis.