Projects
- Research priorities: Disability
- Country: Bangladesh, India
- Budget: € 197,213 | Project number: 707.19.21
- Duration: January 2020 – April 2026
- Status: Ongoing
This study aims to assess the effectiveness of additional doses of Clofazimine in reducing frequency and severity of ENL.
Does additional clofazimine for MB cases at high risk of ENL improve their prognosis/outcome over 2 years?
Project coordination
Project summary
Erythema nodosum leprosum (ENL) is an unpleasant complication of leprosy which can lead to considerable suffering, impaired quality of life, and long term disability. Clofazimine has long been used to reduce severity and recurrence of ENL, however, there is limited published evidence for its effectiveness.
This study intends to test the effectiveness of additional Clofazimine in reducing the incidence and severity of ENL. One group of patients who are suffering from ENL reactions will receive extra doses of Clofazimine for 6 to 12 months. The other group of patients suffering from ENL reactions will be given placebo vitamin tablets to compare the difference in well-being between the two groups. Both groups will also receive standard treatment with steroids, the same as given to people who are not in the trial.
Research question: Does 6- 12months additional administration of Clofazimine medicine to patients under the leprosy treatment or within 12 months of the completion of the treatment and once suffered from ENL reactions, reduce the frequency and severity of the reaction and its consequences in them and possibly have a beneficial effect on their nerve function during the observation period of 24 months.
The research group will assess the results in each group by using standard scales for ENL severity. This will also be done for quality of life as well as nerve damage, and the amount of steroid medication needed. The results will help doctors decide best treatments for ENL patients in future.
Co-financer: Turing Foundation
- Research priorities: Disability
- Country: Indonesia, Nepal
- Budget: € 153,321 | Project number: 707.19.20
- Duration: September 2020 – December 2024
- Status: Ongoing
This study aims to reduce the incidence of dapsone allergy on leprosy patients, by testing the patients’ blood for a genetic markerbefore they receive dapsone as part of their treatment.
Implementation of Dapsone Hypersensitivity Syndrome (DHS) Biomolecular Predictive Test to reduce the incidence of DHS among Leprosy Patients in Papua and Nepal
Project coordination
Partners
Project summary
Leprosy can cause permanent disability, especially if diagnosis and treatment is delayed. Leprosy patients are treated with multi-drug therapy (MDT) for 6-12 months consisting of: dapsone, rifampicin and clofazimine. Dapsone is taken daily. Unfortunately, for some people, dapsone may cause an allergy called dapsone hypersensitivity syndrome (DHS). Dapsone hypersensitivity may cause irreversible organ failure and may be life threatening. Many patients have to be hospitalized for weeks or months or receive intensive care due to DHS. DHS is very severe and traumatic and worsens the stigma of leprosy in the community.
Papua and Mollucas are islands with the largest leprosy population in Indonesia. In those regions, dapsone allergy has an incidence of 3%, with deaths reported in an estimated 10% of dapsone allergy cases. In Nepal, approximately 2% of Anandaban Hospital’s leprosy patients develop dapsone allergy after initiating MDT.
This study aims to reduce the incidence of dapsone allergy on leprosy patients in Papua, Mollucas and Nepal by testing the patients’ blood before they receive dapsone as part of their MDT. As previously shown by the research group, a special blood DNA test can be used to identify if the patient is at high risk for developing dapsone allergy. This test can predict up to 85% of cases that may develop dapsone allergy.
If the patient has the DNA marker, they are at risk for dapsone allergy, and they should not take dapsone for leprosy or any other sickness for the rest of their life. If the marker is absent in the DNA test, the patient is at low risk for dapsone allergy. However, they should still be careful to note any symptoms over the first 4-6 weeks of treatment and notify their doctor of any changes. They could still be in the 15% of cases who develop dapsone allergy without the DNA marker (< 0.5% of leprosy cases).
This study will also provide DNA test instructions in an online, open access publication so that leprosy care providers around the world can use it in clinical settings to better protect patients from dapsone allergy.
Co-funder: Turing Foundation