Topical Imiquimod 5% Cream for Pediatric Plaque Morphea: A Prospective, Multiple-Baseline, Open-Label Pilot Study
| Autor: | Marc Theriault, Andrea Doria, Arun Mohanta, Ronald M. Laxer, Elena Pope |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Male
medicine.medical_specialty Adolescent Erythema Visual analogue scale Pilot Projects Imiquimod Dermatology Ointments Scleroderma Localized Adjuvants Immunologic Skin Ulcer medicine Humans Prospective Studies Child Adverse effect Prospective cohort study Telangiectasia Ultrasonography business.industry Dermis medicine.disease Clinical trial Treatment Outcome Aminoquinolines Female medicine.symptom business Morphea medicine.drug |
| Zdroj: | Dermatology. 223:363-369 |
| ISSN: | 1421-9832 1018-8665 |
| DOI: | 10.1159/000335560 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|