LeprosyPhase 1NCT07806357
Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in ENL
A Phase 1 study testing Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) in people with Leprosy, run by Chittagong Medical College at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leprosy
- What is being tested?
- Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
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.
- Conditions
- Leprosy
- Being tested
- Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| oral Prednisolone alone | Experimental | 10 patient Receives: Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) |
| oral Methotrexate plus Prednisol | Experimental | 9 patient Receives: Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
Primary outcome:
Improvement in Reaction severity assessment score by observing signs and symptoms like tender skin ENL nodules.
Measured: 01.06.2018 to 31.12.2019 total 18 months
Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
Primary outcome:
Improvement in Reaction severity by Physicians Global Assessment changes in number of tender Erythema Nodosum Leprosum skin nodules
Measured: 01.06.2018 to 31.12.2019 total 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chittagong Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Responsible party
- Principal investigator, Mohammad Rafiqul Mowla, Chittagong Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806357
- Sponsor's protocol ID
- CMC/PG/2018/447
- Status last verified
- Sep 2026
- First submitted
- 5 Feb 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)
- ClinicalTrials.gov ID
- NCT07806357
- Acronym / sponsor ID
- CMC/PG/2018/447
- Conditions
- Leprosy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chittagong Medical CollegeUniversity, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral Prednisolone alone | Experimental | Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)10 patient |
| oral Methotrexate plus Prednisol | Experimental | Drug: Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)9 patient |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction)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. | Drug | oral Methotrexate plus Prednisol, oral Prednisolone alone |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Using methotrexate to treat patients with ENL unresponsive to steroids and clofazimine: a report on 9 patientsLink provided by the sponsor.
- Effectiveness of Methotrexate in prednisolone and thalidomide resistant cases of Type 2 lepra reaction: report on three casesLink provided by the sponsor.
- Methotrexate in resistant ENLLink provided by the sponsor.
- A scale to assess the severity of leprosy reactionsLink provided by the sponsor.
- ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum LeprosumLink provided by the sponsor.
- Leprosy reactions in postelimination stage: the Bangladesh experienceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Efficacy and Safety of Prednisolone Monotherapy Versus Prednisolone Plus Methotrexate in Erythema Nodosum Leprosum (Type 2 Lepra Reaction) in people with Leprosy, run by Chittagong Medical College at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.