Complex Cutaneous Leishmaniasis Healing Study in Algeria (LeiClean)

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

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).

Study Overview

• Status: Suspended
• Conditions: Cutaneous Leishmaniases
• Intervention / Treatment: Device: LeiProtect®

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79100
    • NGO Waisenmedizin e. V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 88 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Epithelisation	Digital photo documentation	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
No healing progress with LeiClean	Patients who have to be hospitalised for systemic Sb(V) treatment	2 months

Collaborators and Investigators

• Sponsor: K. W. Stahl
• Collaborators: University of Erlangen-Nürnberg Medical School; Institut Pasteur
• Investigators: Principal Investigator: Zoubir Harrat, Dr., Pasteur Institute

Publications and helpful links

Helpful Links

• Organisation Homepage

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: medical device; complex; zoonotic
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Leishmaniasis; Leishmaniasis, Cutaneous
• Other Study ID Numbers: ALG 17/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No