Study of treatments in Pyoderma Gangrenosum patients - STOP GAP

Phase 1

• Conditions: 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

• Registration Number: EUCTR2008-008291-14-GB
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Study Completion: 2013-01-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 121

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified