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The biomarker of dapsone hypersensitive syndrome in leprosy patients

Study for in intro model of mycobacterial granuloma and its molecular mechanism: the biomarker of dapsone hypersensitive syndrome in leprosy patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-RCC-12002687
Enrollment
Unknown
Registered
2012-11-16
Start date
2009-11-06
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leprosy

Interventions

case (DHS):Non
control1 (leprosy without DHS):Non

Sponsors

Institute of Dermatology,chinese Acadeemy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 68 Years

Inclusion criteria

Inclusion criteria: 1.1 Criteria for enrollment into DHS group; 1) Chinese active leprosy patients or cured patients; 2) Unrestricted gender and age; 3) Must accept dapsone, rifampin, and/or clofazimine triple therapy; in the first 8 weeks of treatment, must show signs and symptoms of DHS, as defined by Richardus and Smiths DHS diagnostic criteria; 4) Must have complete medical records of DHS progression, treatment, and follow-up; 5) Voluntary participation and signing of written informed consents; All of the above criteria for enrollment must be met. 1.2 Criteria for enrollment of dapsone-tolerated leprosy patients; 1) Chinese active leprosy patients or cured patients; 2) Unrestricted gender and age; 3) Good cognitive capacity and memory to provide sufficiently detailed treatment history and/or medical records; 4) Must have used dapsone for more than 8 weeks in the past 3 years without developing signs and symptoms of DHS; 5) Voluntary participation and signing of written informed consents. All of the above criteria for enrollment must be met. 1.3 Criteria for enrollment of healthy participants 1) Chinese ethnicity who are residents of the same provinces as the studys leprosy patients; 2) Age and gender matched with patients in DHS and dapsone-tolerated leprosy patient groups; 3) No history of leprosy; no history of severe systemic disease; 3) Voluntary participation and affirmed oral informed consents; All of the above criteria for enrollment must be met.

Exclusion criteria

Exclusion criteria: Criteria for exclusion from all study groups 1) Non-Chinese ethnicity; 2) Patients whose blood samples cannot be collected; 3) Patients who are at least second degree blood relatives to any other study patient; 4) Drug hypersensitivity symptoms ascribed to any other drug given simultaneously; 5) Severe hepatopathy, hematologic disorder, or other systemic diseases history which may affect DHS evaluation. If there was any of all the criteria above, he or she cannot be enrolled in this study.

Countries

China

Contacts

Public ContactHongsheng Wang
whs33@vip.sina.com+86 13002571330

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026