2. Pyoderma Gangrenosum  Severe, autoinflammatory, ulcerative disease of the skin  Classically presents with rapidly forming, painful ulcers of variable size which can be mutilating  Associated with IBD, inflammatory arthritis and haematological malignancy  Ulcers can take 1-42 months to heal, average time 5 months  Significant economic costs to patient and NHS

3.  Rationale for the study:  No RCTs undertaken in this disease area  Associated with high morbidity for patients and therefore costs to the patient and the NHS  Research question:  Compare head-to-head the two most commonly used systemic treatments. Oral prednisolone (gold standard for patients requiring systemic therapy), will be compared with ciclosporin.  Hypothesis:  Ciclosporin gains control of the disease more rapidly, and reduces the time to healing for patients with PG compared to treatment with oral prednisolone.

4.  Prospective, 2-arm, open, parallel group RCT – with parallel observational study of topical therapy for patients not suitable for systemic therapy  Recruit in c. 50 centres in UK – extend to Europe if recruitment slow  140 patients will be recruited  Assessor of images (for primary outcome) is blinded  Study visits: ◦ baseline ◦ week 2 ◦ week 6 ◦ Final visit (when healed – 6 months maximum)

5. to assess the speed of response to treatment - assessed by digital images at 6 weeks to assess time to complete healing to assess the safety and tolerability of the compared treatments to assess the cost-effectiveness of the compared treatments

6. Refer to a dermatologist who is involved in STOP GAP: Enter all details of who they can refer to Or contact the Trial Manager, Eleanor Mitchell: By phone – 0115 8230489 / 0115 8230486 By email – stopgap@nottingham.ac.ukstopgap@nottingham.ac.uk Prescribe topical therapy if required. Don’t prescribe ciclosporin or prednisolone.