Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00128193 · ClinicalTrials.gov registry record · Phase 2
Leprosy Skin Test Antigens Trial
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT00128193: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00128193 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 260 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00128193, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled. Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use the skin test in high risk volunteers (including individuals with leprosy), healthy individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung disease). Study procedures will include injections, physical exam, and blood testing. Injection sites will be checked several times during the participant's study involvement (5 hours of time spread over approximately 1 month). Volunteers screened for the study, which have leprosy or tuberculosis will be treated or referred for treatment.
Primary Outcome
Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, an
Interventions
- OTHER Placebo
- BIOLOGICAL Tuberculin, Purified Protein Derivative
- OTHER MLSA-LAM
- OTHER MLCwA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2002-04 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00128193 record still lists
NCT00128193 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00128193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00128193 about?
NCT00128193 is a clinical study titled "Leprosy Skin Test Antigens Trial". The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Partic...
What is the current status of trial NCT00128193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2002-04. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00128193?
The interventions under investigation include: Placebo (OTHER), Tuberculin, Purified Protein Derivative (BIOLOGICAL), MLSA-LAM (OTHER), MLCwA (OTHER).
Who is sponsoring clinical trial NCT00128193?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00128193's enrollment target sits among peer trials
260 210th of 2000 higher than 1,789 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02283996 · 260 participants · Phase 4
Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
- NCT03276793 · 260 participants · NA
Brain Connectivity in Depression
- NCT03407469 · 260 participants
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization
- NCT03713125 · 260 participants · NA
Executive Function in Early Childhood
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia