Use of Glucocorticoid alone or plus intravenous immunoglobulin(IVIG) for the Treatment of Severe Drug Eruption

Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003550

Enrollment

Unknown

Registered

2013-09-03

Start date

2011-08-01

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

Stevens-Johnson Syndrome/ toxic epidermal necrolysis

Interventions

Glucocorticoid Group:IVIG 400 mg / kg / d, for 5 days after the withdrawal

Glucocorticoid plus immunoglobulin Group:IVIG 400 mg/kg/d, for 5 days,then IVIG 400 mg / kg / d, for 5 days after the withdrawal

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Males and females aged between 18 and 65 years of age; (2) Diagnosed with severe drug eruption (SJS / TEN) (see "China Clinical Dermatology" on page 751); (3) When the female patients of childbearing age were enrolled in the trial, their urine pregnancy test must be negative, all patients must agree to take contraceptive measures; (4) Provide written informed consent and Willing and able to comply with all aspects of the protocol.

Exclusion criteria

Exclusion criteria: (1) Any systemic corticosteroids therapeutic dosage> 0.5mg/kg/d within 1 weeks prior to randomisation; (2) Suffering from severe neuropsychiatric diseases and endocrine diseases; (3) Associated with other cutaneous manifestations that may affect the efficacy judgments by: viral infections, fungal infections, bacterial infections, syphilis or tuberculosis; (4) patients who are allergic to any ingredient of the drug to be studied; (5) Combined viral infectious liver disease, or severe heart disease, or severe hypertension, or associated with life-threatening gastrointestinal bleeding patients; (6) Pregnant or lactating females; (7) Any other situations not suitable for this study determined by the investigators.

Design outcomes

Secondary

Measure	Time frame
SCORTEN score;Blood pressure;Electrocardiogram;Blood-routine;Urine-routine;Stool routine;Blood biochemical examination;Chest X-ray/CT;Blood cultures and wound bacterial culture;	—

Primary

Measure	Time frame
Reduction of glucocorticoid start time, 28 days total glucocorticoid;Total glucocorticoid;	—

Countries

China

Contacts

Public ContactBaoxi Wang

Institute of Dermatology, Chinese Academy of Medical Sciences

wangbx@ncstdlc.org+86 025-85478071

Outcome results

None listed

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