Cutaneous LeihmaniasisPhase 3NCT07463040
Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL)
A Phase 3 study testing Sodium Stibogluconate (SSG), Miltefosine and Miltefosine + Paromomycin in people with Cutaneous Leihmaniasis, run by Institute of Tropical Medicine, Belgium at 3 sites in Ethiopia.
Trial summary
MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Cutaneous Leihmaniasis
- What is being tested?
- Sodium Stibogluconate (SSG), Miltefosine and Miltefosine + Paromomycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 3 sitesEthiopia
- Study dates
- 1 Jan 2027to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parasitological (microscopy, culture or PCR) confirmation of leishmaniasis
- Age ≥4 and ≤65 years old
- Need systemic treatment based on meeting at least one of the following criteria: >4 lesions/ At least one with lesion size >4cm/ Mucosal involvement, or at risk for mucosal involvement (<1 cm from the nose, eyes or vermillion border of the lips)/ Previous failure of lesion-directed treatment /Lesions on areas not suitable for lesion-directed therapy (e.g. joints, eyelids, fingers)/ Deep or extensive lesion(s) with risk of functional impairment
- Informed consent provided, as follows: For patients ≥18 years of age: Patient is willing and able to provide informed consent. / For patients aged 8 to 17 years (inclusive): Parent or caregiver is willing and able to provide informed consent, and patient is willing and able to provide assent / For patients aged 4 to 7 years (inclusive): Parent or caregiver is willing and able to provide informed consent.
- Willing and able to be hospitalized for the duration of treatment
- Willing and able to attend all follow-up visits
- If female and of child-bearing age: willing to take contraceptives during treatment and for 5 months after EoT (parenteral, intrauterine device (IUD) or implant). Note that actually taking the contraceptives is only required when randomized in an investigational arm containing miltefosine.
Who cannot join
- Pregnant (positive pregnancy test at screening) or breastfeeding
- Any known severe medical comorbidities, or signs and symptoms of severe disease, that in the opinion of the investigator disqualifies the patient of being enrolled in the trial or precludes evaluation of the patient's response to the study medication. Examples are: Severe known active infections such as tuberculosis, schistosomiasis, malaria, hepatitis B virus, active hepatitis C virus/ Serious underlying disease (e.g. cardiac, renal, hepatic (including diabetes mellitus) or chronic disease/ Immunocompromising conditions: transplant patients, or patients receiving immunosuppressant medication/ Pre-existing ocular conditions evaluated at baseline: e.g. keratitis, uveitis, scleritis/ Pre-existing sensorineural hearing loss evaluated at baseline, or previously diagnosed with ototoxicity
- HIV Infection
- Severe malnutrition: ≤5 years old: Mean upper arm circumference (MUAC) <115mm/ 6-10 years old: MUAC <135mm/ 11-17 years old: MUAC <160mm/ ≥ 18 years old: Body mass index (BMI) <16kg/m²
- (History of) ECG abnormalities: Clinically significant cardiac arrythmias: e.g. 2nd degree or 3rd degree AV block without pacemaker, sustained ventricular tachycardia/ Prolonged QTc interval >450ms
- Lab abnormalities: Haemoglobin <5.0g/dL/ Platelets <50 x 10^9/L/ White blood count <1 x 10^9/L / Alanine aminotransferase (AST) / aspartate aminotransferase (ALT) >3x upper limit of normal (ULN)/ Serum creatinine >1.5 x ULN/ Bilirubin >1.5 x ULN/ Fasting blood glucose (preferred) >7mmol/L (126mg/dl) or blood glucose >11.1 mmol/L (200mg/dl) at any time/ Potassium <3.5mmol/L
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- Having received any allopathic treatment for CL lesion(s) in the past 6 months: cryotherapy, thermotherapy, SSG, meglumine antimoniate, paromomycin, pentamidine, liposomal amphotericin B, non-liposomal amphotericin B, miltefosine
- Diffuse cutaneous leishmaniasis (DCL)
- Patients on treatment with any of the prohibited medications, which are any treatments with the potential to influence lesion healing, skin condition, or participant safety. This includes any form of chemotherapy, antituberculosis medication, systemic antibiotics or antifungals, antivirals, corticosteroids and immunosuppressants. Topical antibiotics or antifungals are allowed as long as they are not applied on any of the CL lesions.
- Onset of lesions >24 months ago
- Known allergies or serious adverse reactions to one of the study components/medications
- Any other condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the patient or prevent, limit or confound protocol-specified assessments
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Katrien Clinckx contact
Ethiopia3 sites
ALERT Hospital
Addis Ababa
Shimelis Doni Nigusse, shimelis321@gmail.com
Shimelis Doni
Arba Minch General Hospital
Arba Minch
Mehret Techane, mehrettechane@gmail.com
Mehret Techane
Boru Meda General Hospital
Boru
Wosen Ketema, markwesaketema@gmail.com
Wosen Ketema
About this study
Official title: A Multi-Arm, Multi-Stage Randomized Controlled Clinical Trial Evaluating Systemic Therapeutic Regimens for the Treatment of Cutaneous Leishmaniasis in Ethiopia
MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system.
The multi-centre multi-arm multi-stage phase 3 clinical trial is designed to rigorously evaluate a total of 4 alternative treatment options for systemic CL against Sodium Stibugluconate (SSG) as the standard of care. The trial comprises two seamlessly linked stages. In stage 1, all four investigational arms will be evaluated against the control arm for efficacy to inform the selection of the arms, based on a pre-defined efficacy threshold that will advance to stage 2, in addition to the control arm. After stage 2, the experimental interventions will be compared with SSG similar to a standard superiority trial for efficacy. The general study design in stage 1 and stage 2 will be identical; only the number of investigational arms may differ.
Patients will be randomized into the respective treatment arms at the recruitment sites of Arba Minch hospital, Boru Meda hospital and ALERT hospital in Ethiopia. Individuals will be hospitalized during the entire course of their treatment. As different arms have different treatment duration, patient hospitalization period and visit schedules will differ between arms. In total, the study will last 180 days for each participant.
- Conditions
- Cutaneous Leihmaniasis
- Being tested
- Sodium Stibogluconate (SSG), Miltefosine, Miltefosine + Paromomycin, Liposomal Amphotericin B (LAmB), Pentamidine isethionate
- Keywords
- Multi-Arm Multi-Stage, Standard of care, Sodium stibogluconate, Miltefosine, Paromomycin, Liposomal amphotericin B, Pentamidine, Ethiopia, cutaneous Leishmaniasis
- Medical subject headings
- Leishmaniasis, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Stibogluconate (SSG)Drug
Intramuscular Administration - once daily for 28 days
MiltefosineDrug
Miltefosine - Oral Administration, daily for 28 days
Miltefosine + ParomomycinDrug
Miltefosine - Oral Administration, daily for 28 days + Paromomycine - Intramuscular Administration, once daily for 14 days
Liposomal Amphotericin B (LAmB)Drug
Intravenous Administration, once daily on days 1, 3, 5, 7, 10, 12, 14, 17, 19, 21
Pentamidine isethionateDrug
Intravenous Administration - once daily on days 1, 3, 5, 7, 9, 11, 13
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Standard of Care: Sodium Stibogluconate Receives: Drug: Sodium Stibogluconate (SSG) |
| Miltefosine Arm | Active comparator | Miltefosine Receives: Drug: Miltefosine |
| Miltefosine + Paromomycin Arm | Active comparator | Miltefosine + Paromomycin Receives: Drug: Miltefosine + Paromomycin |
| LamB Arm | Active comparator | Liposomal amphotericin B Receives: Drug: Liposomal Amphotericin B (LAmB) |
| Pentamidine Arm | Active comparator | Pentamidine isethionate Receives: Drug: Pentamidine isethionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each of the investigational arms (miltefosine/miltefosine + paromomycin / liposomal amphotericin B/pentamidine isethionate), to determine whether it has superior efficacy to the control arm in terms of achieving cure of all lesions at Day 90
Cure of all lesions at Day 90, pairwise compared between the control arm and each of the investigational arms.
Cure at the lesion level is defined as 100% improvement of the area of erythema, induration, and ulceration of a lesion compared to the baseline assessment. Cure at the patient level is defined as cure of all lesions present at baseline, and no new lesions appearing. Cure is assessed at multiple timepoints, including Day 90.
Cure at Day 90 is defined as cure assessed at Day 90, or cure assessed at the latest available time point before Day 90, without relapse (known as last observation carried forward (LOCF)).
Measured: Day 90
Secondary outcomes (6)
For each investigational arm, to determine whether it has superior efficacy to the control arm, in terms of achieving cure of all lesions at Day 180.
Cure of all lesions at Day 180, pairwise compared between the control arm and each of the investigational arms .
Cure at Day 180 is defined as cure assessed at Day 180, or cure assessed at the latest available timepoint before Day 180, without relapse (LOCF).
Measured: Day 180
To compare between the control arm and each of the investigational arms: proportion of participants with all lesions cured, cure for all lesions considered individually, the proportion of participants whose index lesion is cured.
Cure at End of Treatment, Day 42, Day 90, and Day 180 at the patient and lesion level.
- Cure of all lesions (patient level) at EoT and D42, pairwise compared between each of the investigational arms and the control arm.
- Cure at End of Treatment, Day 42, Day 90, and Day 180, at the lesion level, adjusted for patient level, pairwise compared between each of the investigational arms and the control arm.
- Cure of the index lesion at End of Treatment, Day 42, Day 90, and Day 180, pairwise compared between each of the investigational arms and the control arm.
Measured: End of Treatment, Day 42, Day 90 and Day 180
To compare between the control arm and each of the investigational arms: proportion of participants that reach at least substantial improvement of all lesions and the index lesion + at least substantial improvement for all lesions individually,
Substantial improvement at participants and lesion level at End of Treatment, Day 42, Day 90, and Day 180 is defined as ≥50%-99% improvement of the area of erythema, induration, and ulceration, compared to the baseline assessment.
Substantial improvement at a specific timepoint is defined as substantial improvement assessed at that timepoint, or at the latest available earlier timepoint.
At least substantial improvement is defined as substantial improvement or cure.
- At least substantial improvement of all lesions (patient level) at EoT, D42, D90, and D180, pairwise compared between each of the investigational arms and the control arm.
- At least substantial improvement at EoT, D42, D90, and D180 at the lesion level, adjusted for patient level, pairwise compared between each of the investigational arms and the control arm.
- At least substantial improvement of the index lesion at EoT, D42, D90, and D180, pairwise compared between each of the investigational arms and control arm.
Measured: End of Treatment, Day 42, Day 90, Day 180
To compare between the control arm and each of the investigational arms, the proportion of participants with treatment failure at Day 42, Day 90, and Day 180.
Treatment failure at Day 42, Day 90, and Day 180. Treatment failure is defined as having the study treatment suspended for any reason as described in section 4.7.2, as having no improvement compared to baseline at Day 42, as having <50% improvement compared to baseline at Day 90, as having anything but all lesions cured at Day 180, or as having worsening of lesions or new lesions compared to the previous visit.
Measured: Day 42, Day 90, Day 180
To assess safety by describing safety & tolerability of each arm by listing number, proportion & severity of AEs/Comparing number, proportion & reason of withdrawals and number & proportion of patients with SAEs between control and investigational arm
Assessment of safety by:
- Number and proportion, type, and severity of adverse events (both all and possibly, probably or definitely related to the study intervention) reported per study arm during the course of the study,.
- Permanent withdrawal from study intervention due to an adverse event that is possibly, probably or definitely related to the study intervention, including reason for withdrawal;
- Having at least one SAE that is possibly, probably or definitely related to the study intervention, between administration of the first dose of study medication and Day 180.
Measured: Day 180
To compare between control arm and each investigational arm, the change in patient-reported outcomes over time between treatment arms
Assessment of patient-reported outcomes by:
- Dermatology Life Quality Index (DLQI) and Children's DLQI (cDLQI): measured at Day 1, Day 42, Day 90, and Day 180 as a discrete number that can be categorized. Change in patient reported outcome will be measured as the difference in score between the subsequent visits (Day 42, Day 90, and Day 180) and Day 1, and compared between arms.
- Cutaneous Leishmaniasis Impact Questionnaire : measured at Day 1, Day 42, Day 90, and Day 180 as a discrete number. Change in patient reported outcome will be measured as the difference in score between the subsequent visits (Day 90, Day 180) and Day 1, and compared between arms.
- Patient and Observer Scar Assessment Score measured at Day 42, Day 90, and Day 180 as a discrete number. Scores for each time point will be compared between arms.
Measured: Day 1, Day 42, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LeihmaniasisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-Arm Multi-stage
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Uppsala University, University of Stellenbosch, Armauer Hansen Research Institute, Ethiopia, Wollo University, Arba Minch University
- Responsible party
- Sponsor
- Investigators
- Johan Van Griensven, Study director, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463040
- Sponsor's protocol ID
- MAMS4CL
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 10 Mar 2026
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Arm, Multi-Stage Randomized Controlled Clinical Trial Evaluating Systemic Therapeutic Regimens for the Treatment of Cutaneous Leishmaniasis in Ethiopia
- ClinicalTrials.gov ID
- NCT07463040
- Acronym / sponsor ID
- MAMS4CL
- Conditions
- Cutaneous Leihmaniasis
- Keywords
- Multi-Arm Multi-Stage, Standard of care, Sodium stibogluconate, Miltefosine, Paromomycin, Liposomal amphotericin B, Pentamidine, Ethiopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Uppsala University, University of Stellenbosch, Armauer Hansen Research Institute, Ethiopia, Wollo University, Arba Minch University
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 10 Mar 2026 (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.
MAMS4CL comprises a clinical trial with three embedded sub-studies designed to comprehensively evaluate the administered treatments and assess the impact of CL treatment on patients and the healthcare system.
The multi-centre multi-arm multi-stage phase 3 clinical trial is designed to rigorously evaluate a total of 4 alternative treatment options for systemic CL against Sodium Stibugluconate (SSG) as the standard of care. The trial comprises two seamlessly linked stages. In stage 1, all four investigational arms will be evaluated against the control arm for efficacy to inform the selection of the arms, based on a pre-defined efficacy threshold that will advance to stage 2, in addition to the control arm. After stage 2, the experimental interventions will be compared with SSG similar to a standard superiority trial for efficacy. The general study design in stage 1 and stage 2 will be identical; only the number of investigational arms may differ.
Patients will be randomized into the respective treatment arms at the recruitment sites of Arba Minch hospital, Boru Meda hospital and ALERT hospital in Ethiopia. Individuals will be hospitalized during the entire course of their treatment. As different arms have different treatment duration, patient hospitalization period and visit schedules will differ between arms. In total, the study will last 180 days for each participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Multi-Arm Multi-stage
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Drug: Sodium Stibogluconate (SSG)Standard of Care: Sodium Stibogluconate |
| Miltefosine Arm | Active comparator | Drug: MiltefosineMiltefosine |
| Miltefosine + Paromomycin Arm | Active comparator | Drug: Miltefosine + ParomomycinMiltefosine + Paromomycin |
| LamB Arm | Active comparator | Drug: Liposomal Amphotericin B (LAmB)Liposomal amphotericin B |
| Pentamidine Arm | Active comparator | Drug: Pentamidine isethionatePentamidine isethionate |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Parasitological (microscopy, culture or PCR) confirmation of leishmaniasis
- Age ≥4 and ≤65 years old
- Need systemic treatment based on meeting at least one of the following criteria: >4 lesions/ At least one with lesion size >4cm/ Mucosal involvement, or at risk for mucosal involvement (<1 cm from the nose, eyes or vermillion border of the lips)/ Previous failure of lesion-directed treatment /Lesions on areas not suitable for lesion-directed therapy (e.g. joints, eyelids, fingers)/ Deep or extensive lesion(s) with risk of functional impairment
- Informed consent provided, as follows: For patients ≥18 years of age: Patient is willing and able to provide informed consent. / For patients aged 8 to 17 years (inclusive): Parent or caregiver is willing and able to provide informed consent, and patient is willing and able to provide assent / For patients aged 4 to 7 years (inclusive): Parent or caregiver is willing and able to provide informed consent.
- Willing and able to be hospitalized for the duration of treatment
Key exclusion criteria (12 listed)
- Pregnant (positive pregnancy test at screening) or breastfeeding
- Any known severe medical comorbidities, or signs and symptoms of severe disease, that in the opinion of the investigator disqualifies the patient of being enrolled in the trial or precludes evaluation of the patient's response to the study medication. Examples are: Severe known active infections such as tuberculosis, schistosomiasis, malaria, hepatitis B virus, active hepatitis C virus/ Serious underlying disease (e.g. cardiac, renal, hepatic (including diabetes mellitus) or chronic disease/ Immunocompromising conditions: transplant patients, or patients receiving immunosuppressant medication/ Pre-existing ocular conditions evaluated at baseline: e.g. keratitis, uveitis, scleritis/ Pre-existing sensorineural hearing loss evaluated at baseline, or previously diagnosed with ototoxicity
- HIV Infection
- Severe malnutrition: ≤5 years old: Mean upper arm circumference (MUAC) <115mm/ 6-10 years old: MUAC <135mm/ 11-17 years old: MUAC <160mm/ ≥ 18 years old: Body mass index (BMI) <16kg/m²
- (History of) ECG abnormalities: Clinically significant cardiac arrythmias: e.g. 2nd degree or 3rd degree AV block without pacemaker, sustained ventricular tachycardia/ Prolonged QTc interval >450ms
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 |
|---|---|---|
| Sodium Stibogluconate (SSG)Intramuscular Administration - once daily for 28 days | Drug | Control arm |
| MiltefosineMiltefosine - Oral Administration, daily for 28 days | Drug | Miltefosine Arm |
| Miltefosine + ParomomycinMiltefosine - Oral Administration, daily for 28 days + Paromomycine - Intramuscular Administration, once daily for 14 days | Drug | Miltefosine + Paromomycin Arm |
| Liposomal Amphotericin B (LAmB)Intravenous Administration, once daily on days 1, 3, 5, 7, 10, 12, 14, 17, 19, 21 | Drug | LamB Arm |
| Pentamidine isethionateIntravenous Administration - once daily on days 1, 3, 5, 7, 9, 11, 13 | Drug | Pentamidine Arm |
Primary outcome
For each of the investigational arms (miltefosine/miltefosine + paromomycin / liposomal amphotericin B/pentamidine isethionate), to determine whether it has superior efficacy to the control arm in terms of achieving cure of all lesions at Day 90
Time frame: Day 90
Cure of all lesions at Day 90, pairwise compared between the control arm and each of the investigational arms. Cure at the lesion level is defined as 100% improvement of the area of erythema, induration, and ulceration of a lesion compared to the baseline assessment. Cure at the patient level is defined as cure of all lesions present at baseline, and no new lesions appearing. Cure is assessed at multiple timepoints, including Day 90. Cure at Day 90 is defined as cure assessed at Day 90, or cure assessed at the latest available time point before Day 90, without relapse (known as last observation carried forward (LOCF)).
6 secondary outcomes
For each investigational arm, to determine whether it has superior efficacy to the control arm, in terms of achieving cure of all lesions at Day 180.
Time frame: Day 180
To compare between the control arm and each of the investigational arms: proportion of participants with all lesions cured, cure for all lesions considered individually, the proportion of participants whose index lesion is cured.
Time frame: End of Treatment, Day 42, Day 90 and Day 180
To compare between the control arm and each of the investigational arms: proportion of participants that reach at least substantial improvement of all lesions and the index lesion + at least substantial improvement for all lesions individually,
Time frame: End of Treatment, Day 42, Day 90, Day 180
To compare between the control arm and each of the investigational arms, the proportion of participants with treatment failure at Day 42, Day 90, and Day 180.
Time frame: Day 42, Day 90, Day 180
To assess safety by describing safety & tolerability of each arm by listing number, proportion & severity of AEs/Comparing number, proportion & reason of withdrawals and number & proportion of patients with SAEs between control and investigational arm
Time frame: Day 180
To compare between control arm and each investigational arm, the change in patient-reported outcomes over time between treatment arms
Time frame: Day 1, Day 42, Day 90, Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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.
Katrien Clinckx contact
Johan Van Griensven study director
Institute of Tropical Medicine, Antwerp, Belgium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Stibogluconate (SSG), Miltefosine and Miltefosine + Paromomycin in people with Cutaneous Leihmaniasis, run by Institute of Tropical Medicine, Belgium at 3 sites in Ethiopia.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart Smekens (+3233455672, bsmekens@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For each of the investigational arms (miltefosine/miltefosine + paromomycin / liposomal amphotericin B/pentamidine isethionate), to determine whether it has superior efficacy to the control arm in terms of achieving cure of all lesions at Day 90 (time frame: Day 90). 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 10 Mar 2026.