Effectiveness of Isotretinoin in Patients with Systemic Lupus Erythematosus Accompanied by Skin Symptoms

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009913

Enrollment

Registered

2024-11-08

Start date

2024-11-25

Completion date

Unknown

Last updated

2024-11-14

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

Conditions

None listed

Interventions

Drug : 1) Drug name: Isotretinoin 2) Ingredients and dosage: Isotretinoin 10 mg 3) Dosage: 0.5 mg/kg/day 4) Route of administration: Oral 5) Formulation: Soft gelatin capsule 6) Storage: Store in a li

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 19 to under 75 years with systemic lupus erythematosus accompanied by skin symptoms related to systemic lupus erythematosus.

Exclusion criteria

Exclusion criteria: Individuals taking medications contraindicated with isotretinoin, those who have previously experienced serious adverse effects from the drug, and pregnant women.

Design outcomes

Primary

Measure	Time frame
Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response	—

Secondary

Measure	Time frame
Changes in individual serologic parameters and absolute values compared with baseline during treatment. (C3, C4, Anti-dsDNA titer, proteinuria);Changes in daily prednisone intake during treatment.;Percentage of participants who achieved a BILAG-based Composite Lupus Assessment (BICLA) response.;Changes in the SLEDAI-2K score during belimumab treatment.	—

Countries

Korea, Republic of

Contacts

Public ContactBong-Woo LEE

The Catholic University of Korea, Seoul St. Mary's Hospital

tdomu1029@gmail.com+82-2-2258-6358

Outcome results