Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

Lepromatous Leprosy Clinical Trial

Official title:

Effect of Additional Clofazimine on ENL Reactions in Leprosy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290744
• Other study ID #: LWM-2010-ENL
• Status: Completed
• Phase: Phase 4
• First received: February 2, 2011
• Last updated: June 3, 2015
• Start date: August 2010
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Leonard Wood Memorial
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Department of Health
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.

Description:

Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Borderline Lepromatous Leprosy
• Lepromatous Leprosy
• Leprosy
• Leprosy, Multibacillary

Intervention

Drug:
• Clofazimine
Clofazimine 100mg daily for 12 months after completion of MDT.
• Placebo
Daily for 12 months

Locations

Country	Name	City	State
Philippines	Cebu Skin Clinic	Cebu	Vesayas

Sponsors (1)

Lead Sponsor	Collaborator
Paul Saunderson

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ENL reactions	The hypothesis is that additional clofazimine will reduce the incidence of ENL reactions in the two years following completion of MDT.	2 years of follow-up	No
Secondary	Severity of ENL reactions	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.	2 years of follow-up	No