Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00919542
Other study ID # ITCRBY24-ENLA
Secondary ID
Status Completed
Phase Phase 2
First received June 11, 2009
Last updated March 21, 2015
Start date July 2010
Est. completion date July 2013

Study information

Verified date March 2015
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority United Kingdom: London School of Hygiene and Tropical Medicine Ethics CommitteeEthiopia: AHRI/ALERT Ethical Review CommitteeEthiopia: National Science and Technology Committee of EthiopiaEthiopia: Drug Administration and Control Authority
Study type Interventional

Clinical Trial Summary

Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum

Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).


Description:

A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Individuals with clinical evidence of new ENL

- Aged 18-65

- Weigh more than 30Kg

Exclusion Criteria:

- Unwillingness to give informed consent

- Patients with severe active infections such as tuberculosis

- Pregnant or breastfeeding women (see Appendix II)

- Those with renal failure, abnormal renal function, hypertensive

- Patients taking thalidomide currently or within the last 3 months

- Patients not willing to return for follow-up

- Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)

- HIV positive patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ciclosporin
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
prednisolone
prednisolone 40mg daily then reducing regimen over 16 weeks

Locations

Country Name City State
Ethiopia Alert Hospital Addis Abeba

Sponsors (4)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia, Homes and Hospitals of St Giles

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of ENL recurrence episodes per patient up to 32 weeks No
Secondary Mean time to ENL recurrence after initial control up to 32 weeks No
Secondary Amount of additional prednisolone required by patients up to 32 weeks No
Secondary Frequency of adverse events for patients in each treatment arm up to 32 weeks No
Secondary Difference in score in Quality of Life assessment between start and end for patients in each treatment arm up to 32 weeks No
See also
  Status Clinical Trial Phase
Completed NCT03302897 - Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers Phase 1
Recruiting NCT05243654 - Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy Phase 2
Completed NCT05091216 - The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients N/A
Completed NCT00860717 - The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients N/A
Recruiting NCT06222372 - Novel Interventions and Diagnostic Tests for Leprosy N/A
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT05597280 - Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy Phase 3
Terminated NCT01751503 - Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer N/A
Active, not recruiting NCT03324035 - Treatment of Neuropathic Pain in Leprosy Phase 3
Completed NCT03683745 - Integrated Mapping of Skin-presenting Neglected Tropical Diseases in Liberia
Recruiting NCT02550080 - Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome Phase 4
Completed NCT02484469 - Impact of the Virtual Human Project on Team-based Learning: A Randomized-controlled Trial N/A
Completed NCT01165840 - Effect of Weight and/or Obesity on Dapsone Drug Concentrations Phase 4
Completed NCT05406479 - Bedaquiline Enhanced Post ExpOsure Prophylaxis for Leprosy (Phase 2) Phase 2
Recruiting NCT03807362 - CC-11050 Trial in Nepalese Patients With Erythema Nodosum Leprosum Phase 2
Completed NCT01006759 - Prevention of Disability: Proposal for a Guidance Manual for Leprosy Patients Phase 1
Completed NCT03662022 - Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar Phase 3
Completed NCT01920750 - Leprosy Skin Test Antigens Phase 1 Phase 1
Recruiting NCT06416033 - Serum Irisin Level In Leprosy Patients
Not yet recruiting NCT03947437 - Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients Phase 1/Phase 2