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Study of hereditary factors associated with increased risk of severe skin reactions in patients who are on anti-epilepsy medicines.

Prevalence of HLA B 1502 (SNP rs144012689) and HLA A 3101 alleles in Indian patients treated with Anti-Epileptic Drugs and its correlation with Severe Cutaneous Adverse Reactions - AED-SCAR study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/06/025709
Enrollment
160
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Control Intervention1: Nil: Nil

Sponsors

Bharati Medical foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases: Patients attending pediatric and adult epilepsy clinic, who are on different anti-epileptic drugs will be screened for past history of drug related rash or new onset rash and a detailed questionnaire will be filled; regarding age of diagnosis, duration of AED, which AED etc. Patients with epilepsy who are on treatment with AED and who have a newly diagnosed or past history of drug induced cutaneous eruptions (rash) on treatment with AED(not deemed to be due to any other cause); and due to which that particular drug was withdrawn. Controls: Patients will be taken from the same clinic, those who are on anti-epileptic drug/s for at least 3 months,but never had any cutaneous reactions.

Exclusion criteria

Exclusion criteria: (i). All patients who have any pre-existing chronic skin disorders like psoriasis, eczema (ii). Patients with known chronic systemic diseases known to be associated with rash (like pemphigus, SLE, vasculitis, etc.) (iii). Patients who are immunocompromised (like primary immunodeficiency disorders, HIV/AIDS) or on drugs which cause immunosuppression (like steroids) (iv). Patients with rash due to accompanying acute conditions like measles, dengue etc. (v). Patients in whom multiple drug additions have been done in last 3 months, due to which it is difficult to ascertain the drug responsible for cutaneous reaction.

Design outcomes

Primary

MeasureTime frame
1. Prevalence ratio of prevalence of HLA B 15:02 carrier status in those with rash versus those without rashTimepoint: 9 months

Secondary

MeasureTime frame
1. Prevalence ratio of patients with positive HLA B 15:02 carrier status in those on aromatic AED with rash on other AED. 2. Prevalence ratio of prevalence of HLA A 31:01 carrier status in those with rash versus those without rash Timepoint: 9 months

Countries

India

Contacts

Public ContactDr Kavita Srivastava

Bharati Vidyapeeth Deemed to be University Medical College, Pune

kavisri1970@gmail.com9850825791

Outcome results

None listed

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