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Methods The STOP GAP trial is a randomised controlled trial (RCT) of oral prednisolone compared to oral ciclosporin for the treatment of PG. The study includes a parallel observation study (case series) for patients requiring topical therapy. Patients who are enrolled into the observational study continue to be followed up and contribute data relating to the efficacy and acceptability of topical treatments. These data provide an important contribution to the available literature on PG, which to-date is based largely on case reports and retrospective case series. An additional benefit of this approach is that patients remain in contact with the research team, and should systemic therapy be indicated, participants are considered for inclusion into the RCT of systemic treatments. This design is efficient and means that most patients who are willing and able to give informed consent are able to contribute to the research activity; this contributes to a broader evidence-base for the treatment of PG patients.

Recruitment into trials of rare conditions - experiences from the STOP GAP trial