Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202605616785682 Date of Registration: 19/05/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness, acceptability, and feasibility of decentralizing the diagnosis and carbon dioxide-based cryotherapy for the treatment of localized cutaneous leishmaniasis in the health centres of South Wollo Zone, Northeast Ethiopia
Official scientific title Effectiveness, acceptability, and feasibility of decentralizing the diagnosis and carbon dioxide-based cryotherapy for the treatment of localized cutaneous leishmaniasis in the health centres of South Wollo Zone, Northeast Ethiopia
Brief summary describing the background and objectives of the trial Cutaneous leishmaniasis remains a significant neglected tropical disease in Ethiopia, where access to timely diagnosis and effective treatment is often limited, especially in peripheral and resource-constrained health facilities. Conventional management is typically centralized and dependent on specialized expertise, creating barriers to care for affected populations at the remote area where the cases are endemic. In this context, this pilot implementation study aimed to assess whether localized cases could be accurately diagnosed and effectively treated at primary health centres by trained frontline staff using carbon dioxide cryotherapy, a simpler and potentially scalable alternative to specialist-based approaches. The study evaluated both feasibility and clinical outcomes under routine health centre conditions, focusing on the ability of non-specialist healthcare workers to identify cases and administer cryotherapy safely and effectively. Following targeted training, health centre staff demonstrated acceptable diagnostic performance and achieved favorable treatment outcomes, including lesion healing with minimal adverse events. These findings support the operational feasibility of a decentralized, task-shifted model of care and highlight the potential for integrating simplified diagnostic and treatment strategies into primary healthcare systems to expand access and strengthen local management of cutaneous leishmaniasis.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 02/12/2024
Actual trial start date 02/12/2024
Anticipated date of last follow up 26/12/2025
Actual Last follow-up date 26/12/2025
Anticipated target sample size (number of participants) 85
Actual target sample size (number of participants) 85
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group carbon dioxide cryotherapy Weekly application: - Two doses on the day of application - 40 seconds for each application - 15 seconds rest in between 3-4months The intervention used carbon dioxide cryotherapy to treat cutaneous leishmaniasis following a standardized, protocol-driven approach. The procedure was carried out at primary health centre in Ethiopia by trained paramedical staff. This intervention employs CO₂ cryotherapy as a decentralized, task-shifting strategy for the treatment of cutaneous leishmaniasis in resource-limited settings. It utilizes portable cryotherapy units that deliver compressed CO₂ gas from pressurized cylinders through a metal probe to achieve rapid tissue freezing and localized destruction of Leishmania-infected cells. The equipment is often already available in primary health centers for cervical cancer screening. This approach eliminates the need for intensive laboratory monitoring and avoids the systemic toxicity associated with conventional antimonial therapies. 85
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age over 12 years Less than 5 lesions Lesion size less than 5cm Lesion located less than 2cm away from the mucosa and non-mucosa lesions Age over 12 years More than or equal to 5 lesions Lesion size less than 5cm Lesions located more than 2cm away from the mucosa and non-mucosa lesions 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2024 College of Medicine and Health Sciences specialized hospital Institutional Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ethiopia Gondar 96 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure or not cure status of the CL lesions At day 90 or at the 3rd months of treatment started
Secondary Outcome Diagnostic capabilities of the health care provided, Quality of life improvement, and adverse events assessed At day 90 or at the 3rd months of treatment started
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Keteteya Health centre Dessie Dessie Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research and Innovation for Global Health Transformation Program London London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Armauer Hansen Research Institute Addis Ababa Addis Ababa Ethiopia Governmental research institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Feleke Tilahun momflk@gmail.com +251945107616 Gondar
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Endalamaw Gadisa endalamaw.gadisa@ahri.gov.et +251911868827 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia AHRI
Role Name Email Phone Street address
Scientific Enquiries Kassahun Alemu kassalemu@gmail.com +251911752466 Gondar
City Postal code Country Position/Affiliation
Gondar Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data, analysis codes, and other supplementary materials will be available Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol We can share the data within one to two months of publication Cutaneous leishmaniasis, Cryotherapy, Carbon dioxide, Effectiveness
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 28/03/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 28/03/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 12/05/2026 I made a change to make the title similar to that of the ethical letter provided by the University. Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: a pilot implementation study in Ethiopia Effectiveness, acceptability, and feasibility of decentralizing the diagnosis and carbon dioxide-based cryotherapy for the treatment of localized cutaneous leishmaniasis in the health centres of South Wollo Zone, Northeast Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 05/05/2026 Scientific title and public title should be made similar while clearly indicating the PICO elements. Treatment outcomes following carbon dioxide cryotherapy for localized cutaneous leishmaniasis Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: a pilot implementation study in Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 05/05/2026 The research title approved in the ethical clearance letter is a broad PhD title encompassing four specific objectives. Each objective will be developed into a separate component of my doctoral research, and this running title represents one of those objectives. Diagnosis of localized cutaneous leishmaniasis and treatment outcomes following carbon dioxide cryotherapy performed by health centre staff: a pilot implementation study in Ethiopia Treatment outcomes following carbon dioxide cryotherapy for localized cutaneous leishmaniasis
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/05/2026 I made a change to make the title similar to that of the ethical letter provided by the University. Treatment outcomes following carbon dioxide cryotherapy for localized cutaneous leishmaniasis Effectiveness, acceptability, and feasibility of decentralizing the diagnosis and carbon dioxide-based cryotherapy for the treatment of localized cutaneous leishmaniasis in the health centres of South Wollo Zone, Northeast Ethiopia
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 04/04/2026 To provide somehow a detailed description of the study The intervention used carbon dioxide cryotherapy to treat cutaneous leishmaniasis following a standardized, protocol-driven approach. The procedure was carried out at primary health centre in Ethiopia by trained paramedical staff. This intervention employs CO₂ cryotherapy as a decentralized, task-shifting strategy for the treatment of cutaneous leishmaniasis in resource-limited settings. It utilizes portable cryotherapy units that deliver compressed CO₂ gas from pressurized cylinders through a metal probe to achieve rapid tissue freezing and localized destruction of Leishmania-infected cells. The equipment is often already available in primary health centers for cervical cancer screening. This approach eliminates the need for intensive laboratory monitoring and avoids the systemic toxicity associated with conventional antimonial therapies. Cutaneous leishmaniasis remains a significant neglected tropical disease in Ethiopia, where access to timely diagnosis and effective treatment is often limited, especially in peripheral and resource-constrained health facilities. Conventional management is typically centralized and dependent on specialized expertise, creating barriers to care for affected populations at the remote area where the cases are endemic. In this context, this pilot implementation study aimed to assess whether localized cases could be accurately diagnosed and effectively treated at primary health centres by trained frontline staff using carbon dioxide cryotherapy, a simpler and potentially scalable alternative to specialist-based approaches. The study evaluated both feasibility and clinical outcomes under routine health centre conditions, focusing on the ability of non-specialist healthcare workers to identify cases and administer cryotherapy safely and effectively. Following targeted training, health centre staff demonstrated acceptable diagnostic performance and achieved favorable treatment outcomes, including lesion healing with minimal adverse events. These findings support the operational feasibility of a decentralized, task-shifted model of care and highlight the potential for integrating simplified diagnostic and treatment strategies into primary healthcare systems to expand access and strengthen local management of cutaneous leishmaniasis.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 12/05/2026 There is no dedicated institutional email for the Institutional Review Board (IRB), but for further information, here is the email address and office phone number. TRUE, College of Medicine and Health Sciences specialized hospital Institutional Research Ethics Committee , Ethiopia, Gondar, 96, Ethiopia, , 08 May 2024, +251911096660, tadeguade2@gmail.com, 41111_38340_4737.pdf TRUE, College of Medicine and Health Sciences specialized hospital Institutional Research Ethics Committee , Ethiopia, Gondar, 96, Ethiopia, , 08 May 2024, +251911096660, info@uog.edu.et, 41111_38340_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 05/05/2026 Apologies, Prof./Dr./Sir. Please find above the personal email address and phone number of the University of Gondar Ethical Committee Directorate Director. As you can see from the ethical clearance letter, I was unable to obtain the directorate’s institutional email address and phone number. TRUE, College of Medicine and Health Sciences specialized hospital Institutional Research Ethics Committee , Ethiopia, Gondar, 96, Ethiopia, , 08 May 2024, +251945107616, momflk@gmail.com, 41111_38340_4737.pdf TRUE, College of Medicine and Health Sciences specialized hospital Institutional Research Ethics Committee , Ethiopia, Gondar, 96, Ethiopia, , 08 May 2024, +251911096660, tadeguade2@gmail.com, 41111_38340_4737.pdf