Using leflunomide to treat skin Henoch-Schonlein Purpura in children
Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children
This study is testing if adding leflunomide to steroid treatment can help children with stubborn skin Henoch-Schonlein Purpura have fewer rashes and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05937880 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of leflunomide combined with steroid therapy for children suffering from refractory skin Henoch-Schonlein Purpura (HSP). It is a prospective, multicenter, one-arm trial that follows participants for one year to assess changes in rash recurrence and other health indicators. The study aims to determine the safety and efficacy of leflunomide in improving remission rates and reducing recurrence of skin purpura in affected children. The results could lead to new treatment strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 to 18 years who have been diagnosed with refractory skin type Henoch-Schonlein Purpura.
Not a fit: Patients with severe underlying diseases or those allergic to leflunomide may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children with refractory skin HSP by reducing rash recurrence.
How similar studies have performed: While there may be limited studies on leflunomide for HSP, the approach of combining it with conventional treatments is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ranges from 1 to 18 years old; 2. Patients meet the HSP diagnostic criteria; 3. Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization. 4. Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: 1. Individuals who are allergic to leflunomide; 2. Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery); 3. Patients with other digestive system diseases; 4. Those who have previously used flumiphene in clinical trials; 5. Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases. 6. Other situations where the researcher deems it inappropriate to participate in the study.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Haiyan Wang, MD
- Email: wanghy78@mail.sysu.edu.cn
- Phone: +8613560489257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.