Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome

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 Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.

Conditions

• Allergic Cutaneous Vasculitis
• Urticaria
• Psoriasis
• Acne
• Bullous Skin Diseases
• Sterile Pustulosis
• Leprosy
• Pneumocystis Pneumonia

Interventions

DRUG

Dapsone

For the HLA-B\*1301 positive subjects, dapsone will not be administrated.

GENETIC

HLA-B*1301

The prospective genetic screening group will be tested before administrating dapsone

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Jinan Central Hospital

  collaborator OTHER

• Shandong Qianfo Hospital

  collaborator UNKNOWN

• Jinan Military General Hospital

  collaborator OTHER

• Qingdao Hiser Medical Group

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Dongying People's Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Dezhou People's Hospital

  collaborator OTHER

• Jinan City Dermatology Hospital Prevention and Treatment

  collaborator UNKNOWN

• Linyi City Dermatology Hospital Prevention and Treatment

  collaborator UNKNOWN

• Jining City Dermatology Hospital Prevention and Treatment

  collaborator UNKNOWN

• Weifang City Dermatology Hospital Prevention and Treatment

  collaborator UNKNOWN

• Laiwu City Dermatology Hospital Prevention and Treatment

  collaborator OTHER

• Rizhao City Dermatology Hospital Prevention and Treatment

  collaborator UNKNOWN

• Shandong Provincial Institute of Dermatology and Venereology

  lead OTHER

Principal Investigators

• Furen Zhang · Shandong Provincial Institute of Dermatology and Venereology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2018-12-31

Completion

2019-05-31

Countries

• China

Study Locations