Complex Cutaneous Leishmaniasis Healing Study in Algeria (LeiClean)
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|ClinicalTrials.gov Identifier: NCT03292835|
Recruitment Status : Suspended (Political Issues in Algeria and now Covod-19 lock-down)
First Posted : September 26, 2017
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment|
|Cutaneous Leishmaniases||Device: LeiProtect®|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Multicentric Non-Interventional Trial Evaluating Painless Hand Hygiene and LeiProtect® Dressing to Treat Complex Cutaneous Leishmaniasis in Algeria - LeiClean|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||March 31, 2023|
- Device: LeiProtect®
Filmogenic dressing gelOther Name: Alcohol Based Hand-Rub (ABHR)
- Lesion Epithelisation [ Time Frame: 2 months ]Digital photo documentation
- No healing progress with LeiClean [ Time Frame: 2 months ]Patients who have to be hospitalised for systemic Sb(V) treatment
Biospecimen Retention: Samples With DNA
Polymerase Chain Reaction (PCR). The differentiation of parasite species in between responders and eventual non-responders using sequencing technologies established in the Institute of Clinical Microbiology, Immunology and Hygiene, FAU Erlangen and University Hospital Erlangen.
Smears with Giemsa staining.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292835
|NGO Waisenmedizin e. V.|
|Freiburg, Germany, 79100|
|Principal Investigator:||Zoubir Harrat, Dr.||Pasteur Institute|