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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03292835
Other study ID # ALG 17/003
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date March 31, 2023

Study information

Verified date September 2020
Source Waisenmedizin e. V. Promoting Access to Essential Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Suspended
Enrollment 100
Est. completion date March 31, 2023
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 90 Years
Eligibility 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)

Study Design


Intervention

Device:
LeiProtect®
Filmogenic dressing gel

Locations

Country Name City State
Germany NGO Waisenmedizin e. V. Freiburg

Sponsors (3)

Lead Sponsor Collaborator
K. W. Stahl Institut Pasteur, University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lesion Epithelisation Digital photo documentation 2 months
Secondary No healing progress with LeiClean Patients who have to be hospitalised for systemic Sb(V) treatment 2 months
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