Cutaneous LeishmaniasesLeiCleanNCT03292835
Complex Cutaneous Leishmaniasis Healing Study in Algeria
An observational study of Cutaneous Leishmaniases, run by K. W. Stahl at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 week to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Leishmaniases
- What is being tested?
- LeiProtect®
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 15 Nov 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria
Who may be able to join
- Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis
- Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility
- Subject gives voluntary consent
Who cannot join
- Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Cutaneous Leishmaniases
- Being tested
- LeiProtect®
- Keywords
- complex, zoonotic, medical device
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeiProtect®Device
Also called Alcohol Based Hand-Rub (ABHR)
Filmogenic dressing gel
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Epithelisation
Digital photo documentation
Measured: 2 months
Secondary outcomes (1)
No healing progress with LeiClean
Patients who have to be hospitalised for systemic Sb(V) treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Nov 2017
- Primary completion15 Nov 2020
- Study completion15 Nov 2020
Why it stopped: Production of LeiProtect suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeishmaniasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- K. W. Stahl
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, University of Erlangen-Nürnberg Medical School
- Responsible party
- Sponsor-investigator, K. W. Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine
- Investigators
- Zoubir Harrat, Dr., Principal investigator, Pasteur Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292835
- Sponsor's protocol ID
- ALG 17/003
- Acronym
- LeiClean
- Status last verified
- Jul 2025
- First submitted
- 18 Sep 2017
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Non-Interventional Trial Evaluating Painless Hand Hygiene and LeiProtect® Dressing to Treat Complex Cutaneous Leishmaniasis in Algeria - LeiClean
- ClinicalTrials.gov ID
- NCT03292835
- Acronym / sponsor ID
- LeiClean / ALG 17/003
- Conditions
- Cutaneous Leishmaniases
- Keywords
- complex, zoonotic, medical device
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Production of LeiProtect suspended.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- K. W. StahlUniversity, hospital or other
- Collaborators
- Institut Pasteur, University of Erlangen-Nürnberg Medical School
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 1 week to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ZCL patients in the CL endemic region of M'Sila and Bou Saada, Algeria
Key inclusion criteria (3 listed)
- Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis
- Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility
- Subject gives voluntary consent
Key exclusion criteria (1 listed)
- Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeiProtect®Also: Alcohol Based Hand-Rub (ABHR)Filmogenic dressing gel | Device | – |
Primary outcome
Lesion Epithelisation
Time frame: 2 months
Digital photo documentation
1 secondary outcome
No healing progress with LeiClean
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Production of LeiProtect suspended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Organisation HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoubir Harrat, Dr. principal investigator
Pasteur Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Leishmaniases, run by K. W. Stahl at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Production of LeiProtect suspended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Epithelisation (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.