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Complex Cutaneous Leishmaniasis Healing Study in Algeria (LeiClean)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Institut Pasteur
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
K. W. Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine

Brief 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).

Condition or disease Intervention/treatment
Cutaneous Leishmaniases 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Intervention Details:
  • Device: LeiProtect®
    Filmogenic dressing gel
    Other Name: Alcohol Based Hand-Rub (ABHR)

Primary Outcome Measures :
  1. Lesion Epithelisation [ Time Frame: 2 months ]
    Digital photo documentation

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT03292835

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NGO Waisenmedizin e. V.
Freiburg, Germany, 79100
Sponsors and Collaborators
K. W. Stahl
Institut Pasteur
University of Erlangen-Nürnberg Medical School
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Principal Investigator: Zoubir Harrat, Dr. Pasteur Institute
Additional Information:
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Responsible Party: K. W. Stahl, Prof. Dr. Dr., Waisenmedizin e. V. Promoting Access to Essential Medicine Identifier: NCT03292835    
Other Study ID Numbers: ALG 17/003
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by K. W. Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine:
medical device
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases