pyoderma gangrenosum MedDRA version: 14.0 Level: LLT Classification code 10037634 Term: Pyoderma gangenosum System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.0 Level: PT Classification code 10037635 Term: Pyoderma gangrenosum System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Neoral soft gelatin capsules
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865133
Trade
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • PG as diagnosed by the recruiting dermatologist. [An ulcerative lesion may have mixed aetiology, but provided the investigator has confidence that a clinical diagnosis of PG is appropriate then they are eligible. Other contributing factors and atypical features will be captured in the case report form]. • Age over 18 years. • Able to provide written, informed consent. Presence of a measurable ulceration (e.g not pustular pyoderma gangrenosum) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant, lactating or at risk of pregnancy. • Granulomatous PG – this condition is very rare and may respond differently to treatment. • Hypersensitivity to study medication • Concomitant ciclosporin, prednisolone or IVIG therapy in the previous month. • Biopsy not consistent with PG. Biopsies will be used to exclude alternative aetiologies (e.g. malignancy, granulomatous PG, arteritis) rather than to confirm the diagnosis of PG, since histology is supportive rather than pathognomic. Ideally, the biopsy will be a 1.5cm rectangular biopsy taken through the edge of the ulcer and left to granulate and heal by secondary intention. Alternatively, 2 separate punch biopsies done at the edge of the ulcer and at the extending margin may be used. It is not normal practice to await histological confirmation before initiating therapy, so patients will be randomised prior to receiving histological results. If the histology indicates an alternative aetiology, the participant will be excluded at that time. • Clinically significant renal impairment, such that you would not normally treat the patient with either prednisolone or ciclosporin • Any pre-treatment investigations, the results of which would prompt you not to use prednisolone or ciclosporin • A diagnosis of malignancy or pre-malignant disease where prednisolone or ciclosporin might interfere with ongoing therapy or might cause harm • The patient has a concurrent medical condition that means that you would not normally treat the patient with either prednisolone or ciclosporin (e.g a degree of hypertension that would lead to not using either of the study drugs, advanced heart failure, poorly controlled diabetes, history of peptic ulcer, malignancy in previous years) • Already participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • 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. ; Main Objective: To evaluate the efficacy and safety of the two most commonly used systemic treatments for PG. The study aims to test the hypothesis that systemic ciclosporin (4 mg/kg/day) is more effective than systemic prednisolone (0.75 mg/kg/day) for oral therapy of PG. Primary objective: To assess the speed of response to treatment - assessed by digital images at 6 weeks. ; Primary end point(s): • Velocity of healing. This will be captured for a single target lesion per patient and measured using digital photography and VEV computerised planimetry. If multiple lesions are present, the target lesion for study will be the largest of those present. Digital images will be taken at baseline and at 6 weeks. In addition, maximum length in the longest axis and maximum width at right angles to this axis will be measured in order to provide some measure of improvement in case of difficulties with the digital images. This will be converted to approximate area by the formula: length x width x 0.785, which approximates to an ellipse for the purpose of randomisation and analysis. This outcome has been chosen as the primary outcome measure as it is 1) unlikely to be compromised by the single-blind nature of the study 2) should result in complete data for almost all participants 3) does not require lengthy follow-up and 4) previous work in patients with venous leg ulcers would suggest that velocity of healing is a good surrogate for subsequent healing. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed