Topical imiquimod 5% cream for pediatric plaque morphea: a prospective, multiple-baseline, open-label pilot study.
OBJECTIVE
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.
Section of Dermatology, The Hospital for Sick Children, University of Toronto, Toronto, Ont., Canada. elena.pope@sickkids.ca
Elena
E
Pope
Andrea S
AS
Doria
Marc
M
Theriault
Arun
A
Mohanta
Ronald M
RM
Laxer
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000634:Aminoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D020405:Dermis / Q000000981:diagnostic imaging / Q000187:drug effects; D005260:Female; D006801:Humans; D000077271:Imiquimod; D008297:Male; D009824:Ointments; D010865:Pilot Projects; D011446:Prospective Studies; D012594:Scleroderma, Localized / Q000000981:diagnostic imaging / Q000188:drug therapy*; D012883:Skin Ulcer / Q000139:chemically induced; D016896:Treatment Outcome; D014463:Ultrasonography
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D009824:Ointments; D000077271:Imiquimod