Skip to main content
OpenTrials
Completed

NCT Number: NCT07806357

Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in ENL

Erythema nodosum leprosum (ENL) is characterized by painful nodules and systemic compromising. It is usually recurrent and/or chronic and has both physical and economic impact on the patient, being a very important cause of morbidity and mortality. In addition, ENL is a major health problem in developing countries like Bangladesh where leprosy is endemic. Therefore, adequate control of this condition is important to reduce morbidity and mortality.

The treatment of ENL is usually started with steroids which have many adverse effects when given for prolonged periods and in high doses. However, recently in some case reports MTX appears to have a beneficial effect in cases of ENL. Also, MTX may provide a cheaper and convenient option in management of ENL.

However, there is paucity of well-designed randomized controlled trial on the effectiveness of MTX in the treatment of ENL. In this context such studies are needed. The investigator therefore designed this randomize trial to evaluate the efficacy and safety of combined MTX and Prednisolone over Prednisolone monotherapy in local setting. The investigator combined reducing doses of Prednisolone with a low dose MTX to minimize dose related complications, while maximizing benefit in controlling ENL. If the study results would show the superiority of combined regimen as found elsewhere in the World, it would be helpful to reduce the morbidity of ENL Patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chittagong Medical College

Chittagong, 4203, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with ENL had crops of tender subcutaneous skin lesions with systemic features including fever (temperature >38°C), neuritis, joint pain, bone tenderness, orchitis, iritis, oedema, malaise, anorexia and lymphadenopathy.
  • Patients of both sexes with age ranging 18 years to 65 years.

Exclusion criteria

  • Erythema nodosum associated with other disorder.
  • Pregnant and lactating women.
  • Diagnosed case of chronic hepatic, renal, hematological or other connective tissue disorders, Osteoporosis.
  • Severely ill, immune-suppressed patients like HIV/AIDS and patients of internal malignancy.
  • Patients or guardians not willing to participate in the study by signing informed consent form.

Treatment and study plan

Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

Drug

For Group A:

Each of the selected patients of group A received Tablet Methotrexate 2.5 mg 3 doses (12 hour apart), 7.5mg per week for 6 months and Tablet Prednisolone (40mg/day) tapering over 3 months. Reducing 5 mg of prednisolone every 2 weekly up to 20 mg/day then 5 mg every week for 1 month. And Methotrexate was used 7.5 mg weekly as maintenance dose.

For Group B:

Patients of group B received Prednisolone (40mg/day) tapering over 6 months. Reducing 5 mg every 2 weeks up to 20 mg (2 months) then 20 mg continued for 10 weeks. Then reduced 5 mg every 2 weeks up to 24 weeks.

Primary outcomes

  1. Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

    Time frame: 01.06.2018 to 31.12.2019 total 18 months

    Primary outcome:

    Improvement in Reaction severity assessment score by observing signs and symptoms like tender skin ENL nodules.

  2. Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

    Time frame: 01.06.2018 to 31.12.2019 total 18 months

    Primary outcome:

    Improvement in Reaction severity by Physicians Global Assessment changes in number of tender Erythema Nodosum Leprosum skin nodules

Sponsors and collaborators

Lead sponsor

Chittagong Medical College

Other

Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Registry information

Official study title

Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.