Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Apremilast in Patients of Chronic and Recurrent Erythema Nodosum Leprosum
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Erythema Nodosum Leprosum
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Leprosy is a chronic infectious disease caused by Mycobacterium leprae. The disease manifests with a varied spectrum, ranging from localized tuberculoid leprosy (TT) to generalized lepromatous leprosy...
Detailed Description
ENL is confined to leprosy patients classified as BL or LL (Ridley-Jopling), which in turn comprise the multi-bacillary (MB) patient group, as defined by WHO. ENL presents as new, red, painful and ten...
Eligibility Criteria
Inclusion
- Chronic and recurrent ENL cases of leprosy regardless of age, sex and treatment status with MDT
- Patients not responded with paracetamol, clofazimine, pentoxifylline, colchicine, methotrexate, azathioprine, TNF inhibitors etc.,
- Patients who can give valid consent.
- Willing for monthly follow-up visits for at least 3 months.
Exclusion
- Pregnant and lactating mothers
- Severe renal dysfunction
- Patients with HIV, Hepatitis B and Hepatitis C
- Inability to come for monthly follow up visits for 6 months
- Those who cannot provide consent for the study
- Known case of psychiatric disease
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04822909
Start Date
September 15 2019
End Date
June 30 2020
Last Update
March 30 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology OPD, New OPD Building, Level 5C, Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
2
PGIMER
Chandigarh, India, 160012
3
Tarun Narang
Chandigarh, India, 160012