Acne fulminans
Conditions
Interventions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
12 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age >=12 years, body weight >25 kg; 2. Diagnosed as acne fulminans: acute onset of severe inflammatory nodules and cysts with hemorrhagic necrosis, erosion or ulceration, hemorrhagic crusts on the surface, significant pain, involving the upper trunk (mainly chest and back) and/or face; with or without systemic symptoms (fever, fatigue, arthralgia/myalgia, and/or significantly elevated laboratory inflammatory markers); Investigator's Global Assessment (IGA) grade 4 (very severe); 3. No prior use of JAK inhibitors, IL-17A, TNF-a, IL-12/IL-23 or IL-23p19 biologics; 4. Signed informed consent (from both the minor participant and their parent(s)/legal guardian(s) for underage subjects).
Exclusion criteria
Exclusion criteria: 1. Active infections (e.g., tuberculosis, HBV, HCV, HIV, herpes virus infection, etc.); 2. Malignant tumors or history of malignancy; 3 Pregnant or lactating women; 4. Unwilling to use contraception during study drug treatment; 5. Comorbid pyoderma gangrenosum, hidradenitis suppurativa, or other autoimmune skin diseases; 6. Active inflammatory bowel disease (including Crohn's disease and ulcerative colitis); 7. Use of systemic corticosteroids, isotretinoin, systemic antibiotics, or photodynamic therapy within 1 month prior to enrollment; 8. Laboratory abnormalities: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) = 2.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² (calculated using the 2021 CKD-EPI creatinine equation). 9. Other conditions deemed inappropriate by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of GAGS score;Reduction rate of inflammatory lesion count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Change in total lesion count and lesion subtype counts;Change in pain/tenderness NRS score of skin lesions;Change in ECCA acne scar score;Change in Acne-QoL score;Improvement of systemic symptoms and inflammatory markers in acne fulminans; | — |
Countries
China
Contacts
Public ContactXiang Wen
West China Hospital of Sichuan University
Outcome results
None listed