A Phase 3 interventional study of Fusidic Acid and Vehicle cream in Leishmaniasis, Cutaneous, sponsored by Institute of Tropical Medicine, Belgium. Not yet recruiting at 2 sites in Ethiopia. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Institute of Tropical Medicine, Belgium · Phase 3, Interventional, and Treatment
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:
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's planned enrollment of 180 is above the median of 80 across 133 interventional studies indexed under Leishmaniasis.
Browse Leishmaniasis studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinically suspected complicated CL patients visiting the study site meeting the following inclusion criteria and none of the exclusion criteria:
Inclusion:
Need for systemic treatment (1 or more of these criteria)
At least one lesion eligible for treatment* (meeting all criteria below)
Exclusion:
Abnormal lab values
4 weeks SSG (SoC) with 2 weeks twice daily topical application of fusidic acid 2% cream
Drug: Fusidic Acid
4 weeks SSG (SoC) with 2 weeks twice daily topical application of vehicle cream
Other: Vehicle cream
4 weeks SSG (SoC) only
Fusidic acid 2% cream
Cetomacrogol cream
Improvement of index lesion at EoT
To assess if 4 weeks SoC with 2 weeks application of 2% fusidic acid twice per day (Arm 1, Treatment) is superior to 4 weeks SoC only (Arm 3, Control) for complicated CL patients, in terms of reaching at least substantial improvement\* of the index lesion\*\* at the end of treatment (EoT). \*Substantial improvement is defined as \>50% flattening and \>50% re-epithelization compared to the baseline assessment. Improvement will be measured for each lesion. At least the index lesion needs to be improved or cured for a patient to be considered substantially improved. \*\*Index lesion is defined as the largest lesion eligible for treatment.
Time frame: 28 days
Arm 1 superiority to arm 3 - index lesion
To assess if Arm 1 is superior to Arm 3, using an ordinal (no improvement, minor improvement, substantial improvement, cure, relapse) and continuous (% re-epithelization/flattening) outcome measures for the index lesion at EoT and D42
Time frame: 42 days
Arm 1 superiority to arm 3 - lesions eligible for treatment
To assess if Arm 1 is superior to Arm 3, using binary (at least substantial improvement), ordinal (no improvement, minor improvement, substantial improvement, cure, relapse) and continuous (% re-epithelization/flattening) outcome measures for all lesions eligible for treatment individually and combined at EoT and D42
Time frame: 42 days
Proportion of participants that reach substiantial improvement - arm 1 vs arm 2
To compare the proportion of patients that reach at least substantial improvement of the index lesion, all lesions combined and individually at EoT and D42 between patients who received SoC with topical 2% fusidic acid (Arm 1, Treatment), and those who received SoC combined with topical vehicle cream (Arm 2, Vehicle)
Time frame: 42 days
Proportion of participants that reach substiantial improvement - arm 2 vs arm 3
To compare the proportion of patients that reach at least substantial improvement of the index lesion, all lesions combined and individually at EoT and D42 between patients who received SoC combined with topical vehicle cream (Arm 2, Vehicle), and those who received SoC only (Arm 3, Control)
Time frame: 42 days
Cycles needed for final cure
To compare the number of cycles needed to reach final cure per treatment arm
Time frame: 180 days
Proportion of cured patients at day 180
To determine the proportion with 95% CI of patients that reach cure without relapsed or worsening at day 180 for the three treatment arms
Time frame: 180 days
Quality of life - patient reported outcome
To compare change over time of patient-reported outcomes - the dermatological life quality index (DLQI) scores and global assessment - per treatment arm
Time frame: 180 days
Safety and acceptability
To assess safety and acceptability of treatment arms a) Withdrawal from study intervention: proportion and 95% CI of patients withdrawn from intervention, per arm b) Adverse events: number and proportion of patients with adverse events, per arm c) Cumulative incidence of adverse events (AEs) related to the study drug d) Recommendability: acceptability and recommendability score (0-10) given by patients after treatment completion, per arm
Time frame: 180 days
Stability microbial diversity
To determine the stability of microbial diversity in the healthy skin over time
Time frame: 180 days
Increase microbial diversity
To assess the increase in microbial diversity indices within each trial arm at D14, EoT, D42 and M6 compared to D0.
Time frame: 180 days
Correlation microbial diversity and substantial improvement
To determine whether increase in microbial diversity at EoT compared to D0 is correlated with substantial improvement of the index lesion and all lesions combined at EoT for the three trial arms
Time frame: 180 days
Correlation microbial diversity and cure without relapse
To determine whether increase in microbial diversity at M6 compared to D0 is correlated with cure without relapse at M6, for the three trial arms
Time frame: 180 days
Plan to share: No
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Institute of Tropical Medicine, Belgium