Topical Imiquimod 5% Cream for Pediatric Plaque Morphea: A Prospective, Multiple-Baseline, Open-Label Pilot Study

Abstract

Background/Aims: Therapeutic options for the treatment of plaque morphea are limited. We explored the efficacy and safety of imiquimod cream in children with plaque morphea. Methods: Prospective, open-label, double-baseline study, using imiquimod 5% cream topically for 9 months. The primary outcome measure was improvement in the thickening of morphea plaques using a visual analog scale (VAS) and the DIET score (dyspigmentation/induration/erythema/telangiectasia). Secondary outcome measures were clinicoradiographic correlations and frequency of adverse events. Results: Nine patients, 89% females, with a mean age of 11.33 years (SD = 3.52) were enrolled. At 36 weeks, the mean VAS had decreased from 48.08 (SD = 18.85) to 22.7 (SD = 12.9) (p < 0.0001), and the mean DIET score from 4.38 (SD = 1.2) to 3.06 (SD = 1.39) (p = 0.23). There was very good interrater reliability between DIET score assessments (intraclass correlation coefficient, ICC = 0.75) and VAS (ICC = 0.59) and moderate agreement between parent and investigator VAS (ICC = 0.5). Ultrasonographically measured dermis thickness changed from 1.05 (SD = 0.34) to 0.95 (SD = 0.19) (p = 0.001). One patient experienced ulceration that required temporary discontinuation of intervention. Conclusions: This proof of concept study revealed that imiquimod 5% cream is effective in decreasing the thickening of plaque morphea and safe for pediatric use. Further prospective studies are warranted.

Discordance of pediatric morphea treatment by pediatric dermatologists

“…Multiple options exist and are commonly used when treating mild morphea in children, but few of these options are based on evidence. The existing studies involve the use of such topical immunomodulators as tacrolimus, imiquimod, and calcipotriene, of which our study population commonly chose tacrolimus and calcipotriene, but the small sample size and often the lack of a control group limited these studies . Topical corticosteroids, the form of topical medication that dermatologists use most commonly for pediatric morphea, have never been studied in the treatment of pediatric morphea .…”

“…A recent survey of clinicians in the United Kingdom reported that topical corticosteroids are the most commonly used medication to treat plaque morphea, but no evidence was provided regarding their use . Topical immune modulators, including calcineurin inhibitors, calcipotriene, and imiquimod, are often used but have been evaluated only in small studies without the use of a control group . Lack of consensus on objective outcome measures also limits studies.…”

European Dermatology Forum S1‐guideline on the diagnosis and treatment of sclerosing diseases of the skin, Part 1: localized scleroderma, systemic sclerosis and overlap syndromes

“…36 So far, studies on pimecrolimus for LS are missing. The topical immune response modifier imiquimod has been reported to significantly improve abnormal pigmentation, sclerosis and erythema in LS [37][38][39] but cannot be recommended for LS until more valid data are available. Intralesional interferon gamma did not prove effective in LS in a double-blinded, placebo-controlled trial.…”

Scleroderma: Nomenclature, etiology, pathogenesis, prognosis, and treatments: Facts and controversies

“…49,50 Treatment with twice-daily topical tacrolimus is supported by a randomized placebo-controlled trial. 52 Additional topical therapies that have shown benefit in prospective studies include topical imiquimod applied three to five times per week, 53,54 combination calcipotriol and betamethasone dipropionate applied once to twice daily, 55 and calcipotriene applied and occluded twice daily. 56 Topical steroids, anecdotally the most commonly used therapy for plaque morphea, may be effective, but to date there are no data supporting their efficacy as a solitary agent.…”