Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Compl… (NCT06695143) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia
Ethiopia180 participantsStarted 2025-04
Plain-language summary
This clinical trial aims to evaluate the effectiveness of combining the standard treatment for complicated cutaneous leishmaniasis (CL), sodium stibogluconate (SSG), with either topical fusidic acid 2% cream or a vehicle cream without active ingredient. The goal is to assess whether this combination improves treatment outcomes by restoring the balance of the skin microbiome (dysbiosis) in patients with severe CL, a condition common in Ethiopia.
The study will compare three treatment groups:
* Fusidic Acid Group: SSG plus topical fusidic acid for 2 weeks.
* Vehicle Cream Group: SSG plus topical vehicle cream for 2 weeks.
* Control Group: SSG only, with no topical treatment.
The primary objective is to determine if the addition of fusidic acid improves treatment outcomes compared to SSG alone, as measured by substantial improvement in the index lesion at the end of treatment (EoT).
A total of 180 patients will be enrolled at two hospitals in Ethiopia. The trial will run for 24 months, with a focus on understanding how restoring the skin microbiome can improve CL treatment outcomes and potentially provide a low-cost, accessible treatment strategy for CL patients.
Who can participate
Age range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Clinically suspected complicated CL patients visiting the study site meeting the following inclusion criteria and none of the exclusion criteria:
Inclusion:
* Clinical diagnosis of CL
* Need for systemic treatment (1 or more of these criteria)
* Mucosal involvement of lesion or at risk for mucosal involvement (\< 1 cm from the nose, eyes and vermillion border of the lips)
* Lesion size \>4 cm
* \>4 lesions
* Lesions on joints or fingers
* Lesions previously not responding to local treatment
* Lesions unsuitable for local treatment (e.g., eyelids)
* Lesions with signs of dissemination (satellite lesions, nodular lymphangitis, sporotrichoid pattern)
* Age \> 4 (minimum age to receive systemic treatment with SSG)
* At least one lesion eligible for treatment\* (meeting all criteria below)
* lesion with surface change, including ulcerated, crusted and scaly lesions
* distinguishable from other lesions (minimum 0.5 cm apart)
* no mucosal involvement against which a topical agent would likely not be effective (e.g., lesions that are located too deep within the nasal passages or on the inner lip, where proper application is challenging and the ointment may be easily removed or not adequately absorbed)
* Willing and able to provide informed consent. For participants under the age of 18, parental or caregiver consent is required. Additionally, assent must be obtained from adolescents aged 12 to 17
* Willing to be hospitalized for 4 weeks
Exclusion:
* DCL patie…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.