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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases

NCT05732987

Neutrophil-mediated Inflammatory Dermatoses Inflammatory Dermatoses

RECRUITING

A Study to Explore Safety, Pharmacokinetics, and Early Clinical Signal of Efficacy of DS-2325a in Patients With Netherton Syndrome

NCT05979831

Netherton Syndrome

TERMINATED PHASE1/PHASE2

SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)

NCT07021495

Chronic Spontaneous Urticaria (CSU) Hidradenitis Suppurativa (HS) Psoriasis (PsO) +2 more

RECRUITING

The Association of Bullous Pemphigoid With Dipeptidyl-peptidase 4 Inhibitors

NCT04469582

Bullous Pemphigoid

UNKNOWN

Evaluation of TNF-α Blockade Effect in Patients With Severe Cutaneous Adverse Drug Reactions

NCT01276314

Drug Hypersensitivity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The prospective genetic screening arm

Prospective HLA-B\*1301 screen before administrated treatment included dapsone

Group Type EXPERIMENTAL

Dapsone

Intervention Type DRUG

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

HLA-B*1301

Intervention Type GENETIC

The prospective genetic screening group will be tested before administrating dapsone

The control arm

No HLA-B\*1301 screen before administrated treatment included dapsone

Group Type ACTIVE_COMPARATOR

Dapsone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dapsone

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

Intervention Type DRUG

HLA-B*1301

The prospective genetic screening group will be tested before administrating dapsone

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosed with cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration.
* Subjects are dapsone-naive.
* All subjects must have a clinical need for treatment with dapsone that precedes the decision to participate in the study.
* All subjects are willing to complete the 6-weeks period clinical trial.
* All subjects are written informed consent.

Exclusion Criteria

* Has previously received Dapsone therapy.
* The subject or any of their healthcare providers is aware of the subjects HLA type.
* Has been diagnosed with Glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency
* Satisfies any contraindications or restrictions to Dapsone therapy as listed in the product labels.
* Current severe illness, including heart, liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
* Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study \[alanine aminotransferase (ALT), glutamic oxaloacetic transaminase(ALT), et al).
* Pregnant women or women who are breastfeeding.
* Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.
* A positive result for HLA-B\*1301 in those subjects randomised to the genetic screening arm.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No