Complex Cutaneous Leishmaniasis Healing Study in Algeria

NCT03292835 | Terminated DMC

• 1 other identifier: ALG 17/003
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cutaneous Leishmaniases

Keywords

complex; zoonotic; medical device

Outcome Measures

Primary Outcomes (1)

• Lesion Epithelisation

  Digital photo documentation

  2 months

Secondary Outcomes (1)

• No healing progress with LeiClean

  2 months

Interventions

LeiProtect® DEVICE

Filmogenic dressing gel

Also known as: Alcohol Based Hand-Rub (ABHR)

Eligibility Criteria

• Age: 1 Week - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Subject has Giemsa and PCR proven L.major cutaneous leishmaniasis
• Subject has complex zoonotic cutaneous leishmaniasis or Sb(V) incompatibility
• Subject gives voluntary consent

You may not qualify if:

• Immune deficiencies, skin tumours, allergy to 1,2-propylene glycol (rare)

Sponsors & Collaborators

• K. W. Stahl: lead
• Institut Pasteur: collaborator
• University of Erlangen-Nürnberg Medical School: collaborator

Study Sites (1)

NGO Waisenmedizin e. V.

Freiburg im Breisgau, 79100, Germany

Location

Related Links

• Organisation Homepage

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.

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zoubir Harrat, Dr.

  Pasteur Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 26, 2017
• Study Start: November 1, 2017
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

DE (1)