Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01290744 |
Recruitment Status :
Completed
First Posted : February 7, 2011
Last Update Posted : June 4, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Borderline Lepromatous Leprosy Lepromatous Leprosy | Drug: Clofazimine Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Additional Clofazimine on ENL Reactions in Leprosy |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo group
These patients will receive placebo for 12 months after completion of MDT.
|
Drug: Placebo
Daily for 12 months
Other Name: Vitamin capsule |
Experimental: Clofazimine for 12 months after MDT
Patients will be given clofazimine (100mg daily) for 12 months after completion of MDT.
|
Drug: Clofazimine
Clofazimine 100mg daily for 12 months after completion of MDT.
Other Name: Lamprene |
- Incidence of ENL reactions [ Time Frame: 2 years of follow-up ]The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.
- Severity of ENL reactions [ Time Frame: 2 years of follow-up ]The hypothesis is that additional clofazimine will reduce severity of ENL reactions, as well as incidence. Severity will be monitored by three indicators: 1. a rather crude clinical score (mild, moderate or severe), 2. the total dose of prednisolone given to treat ENL reactions, 3. the total duration of ENL symptoms.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 15 to 70 years of age
- MB leprosy
- Pretreatment BI of 4 or more at any site
- Consent
Exclusion Criteria:
- Presence of another serious illness
- Refusal of informed consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290744
Philippines | |
Cebu Skin Clinic | |
Cebu, Vesayas, Philippines, 6000 |
Principal Investigator: | Marivic Balagon, MD | LWM |
Responsible Party: | Paul Saunderson, Scientific Director, Leonard Wood Memorial |
ClinicalTrials.gov Identifier: | NCT01290744 |
Other Study ID Numbers: |
LWM-2010-ENL |
First Posted: | February 7, 2011 Key Record Dates |
Last Update Posted: | June 4, 2015 |
Last Verified: | June 2015 |
leprosy ENL clofazimine |
Leprosy Leprosy, Lepromatous Leprosy, Multibacillary Mycobacterium Infections, Nontuberculous Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Infections Clofazimine Anti-Inflammatory Agents Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents |