Complex Cutaneous Leishmaniasis Healing Study in Algeria

Cutaneous Leishmaniases Clinical Trial

— LeiClean  

Official title:

Multicentric Non-Interventional Trial Evaluating Painless Hand Hygiene and LeiProtect® Dressing to Treat Complex Cutaneous Leishmaniasis in Algeria - LeiClean

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03292835
• Other study ID #: ALG 17/003
• Status: Suspended
• 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
• 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)

Related Conditions & MeSH terms

• Cutaneous Leishmaniases
• Leishmaniasis
• Leishmaniasis, Cutaneous

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

External Links

•   Organisation Homepage