Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome
Status:
Unknown status
Trial end date:
2019-05-01
Target enrollment:
Participant gender:
Summary
This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of
dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those
patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin
diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need
dapsone administration. The study has two (co-primary) objectives: i) to determine if
screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of
clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to
determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a
significantly lower incidence of immunologically-confirmed DHS versus current standard of
care (no genetic screening or patch testing). The study consists of up to a 5-day screening
period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing
a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT)
assessment period. Eligible subjects will be randomised to one of two study arms: a Current
Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm
(prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the
prospective Genetic Screening Arm will not receive dapsone and will be excluded from further
study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn
from dapsone and undergo EPT patch testing 6 weeks later.
Phase:
Phase 4
Details
Lead Sponsor:
Shandong Provincial Institute of Dermatology and Venereology
Collaborators:
Dezhou People's Hospital Dezhou People's Hospital,Shandong Dongying People's Hospital,Shandong Jinan Central Hospital Jinan City Dermatology Hospital Prevention and Treatment Jinan Military General Hospital Jining City Dermatology Hospital Prevention and Treatment Laiwu City Dermatology Hospital Prevention and Treatment Liaocheng People's Hospital Linyi City Dermatology Hospital Prevention and Treatment Qingdao Center Medical Group Qingdao Hiser Medical Group Rizhao City Dermatology Hospital Prevention and Treatment Shandong Jining No. 1 People's Hospital Shandong Jining No.1 People's Hospital Shandong Provincial Hospital Shandong Qianfo Hospital Weifang City Dermatology Hospital Prevention and Treatment