Imiquimod Cream 5% for Recalcitrant Cutaneous Warts in Immunosuppressed Individuals

C.A. Harwood, C.M. Perrett; V.L. Brown; I.M. Leigh; J.M. Mcgregor; C.M. Proby

Disclosures

The British Journal of Dermatology. 2005;152(1):122-129. 

In This Article

Methods

Fifteen patients attending a dedicated adult organ transplant and immunosuppression (OTI) dermatology clinic at Bart's and the London NHS Trust were recruited to this study. Patients were eligible if they had a minimum of eight clinically typical viral warts on the hands/forearms and/or feet, which had been present for at least 18 months and which had been documented by physician review in the OTI clinic to be both persistent and refractory to standard treatment of 12 or more weeks of a topical salicylic acid preparation and four or more cycles of cryotherapy. In the case of OTRs, it was required that blood creatinine levels and immunosuppressive treatment regimens over the previous 12 months were stable. All patients gave informed consent before participation.

After a wash-out period of 4 weeks during which all previous therapies were stopped, warts were mapped photographically and diagrammatically and classified as either common warts or plane warts. Hyperkeratosis was further classified as either mild (+), moderate (+ +) or severe (+ + +). The warts to be treated were chosen such that there were approximately equivalent numbers and type of warts on the opposite hand/forearm or foot to act as internal controls. Patients were asked to minimize hyperkeratosis of both test and control warts by regular filing (with an emery board or pumice stone). They were instructed on self-application of imiquimod cream and requested to rub a thin layer of the cream on the clean wart area, to leave on overnight for a minimum of 8 h, and to remove with mild soap and water. Only warts that had previously been specifically identified and documented were treated. Patients were not permitted to apply topical preparations other than simple emollients to contralateral control warts. Imiquimod was initially applied to the test warts on 3 days per week for 8 weeks. If warts were unresponsive, this was increased to daily application for 8 weeks. Thereafter, unresponsive warts were treated with imiquimod applied under occlusion (with OpSite®, Tegaderm® or clingfilm) for 8 weeks. Study completion was defined as either completion of at least 24 weeks of therapy, or use of imiquimod until warts cleared (if occurring before 24 weeks).

Follow-up examination was performed by one physician (C.A.H.). Patients were seen 1 week, 2 weeks and 4 weeks after initiation of treatment. Thereafter examinations were performed at 4-week intervals for the duration of therapy. At the end of therapy, patients were reviewed at a minimum of 6-monthly intervals for a further 18 months. At each visit clinical responses of both control and treated warts were recorded. The presence or absence of each wart was noted and a visual and photographic assessment of the percentage change in size was also made (although the surface area/volume of each wart was not formally calculated). Symptoms and signs suggestive of local reactions were documented, including pruritus, discomfort, erythema, erosions, ulceration, crusting, skin infection and scarring. These were graded as 'mild' (a visible local skin reaction without discomfort that did not interrupt daily activities); 'moderate' (a local skin reaction associated with considerable discomfort but no disruption of daily activities); and 'severe' (a local skin reaction that substantially interferes with normal daily activities). Baseline full blood count, serum electrolytes, urea and creatinine and liver function tests were measured before treatment and at each subsequent review.

Ethical approval for this study was obtained from the East London and City Health Authority Local Ethics Committee.

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