Abstract
OBJECTIVE : A post-marketing surveillance study was performed to investigate the efficacy and safety of PenlesⓇ Tape 18 mg containing 18 mg of lidocaine for pain relief during molluscum contagiosum removal in children.
RESULT : A total of 593 patients were enrolled between January 2013 and January 2014, of which 500 patients were included in a safety analysis. Molluscum contagiosum has a high incidence in 3-5 years old. Of the patients enrolled in this study, 40.2% were aged “ 4 years.
About 53.9% of the patients exhibited “No physical response on removal,” 37.1% of the patients showed “Slight physical response on removal” and this was considered the pain threshold level, and 8.5% of the patients showed “Considerable physical response on removal.”
Adverse drug reactions （ADR） included 4 cases of erythema and 2 cases of contact dermatitis in 6 patients （incidence : 1.20%）. All ADRs were localized, reversible, and not serious. ADRs related to the anesthetic action of lidocaine were not observed.
About 68.2% and 25.8% of the doctors rated PenlesⓇ Tape 18 mg as “Very Useful” and “Useful,” respectively. Therefore, we believe that this drug has very high utility.
CONCLUSION : The results of the present study confirmed the efficacy and safety of PenlesⓇ Tape 18 mg for pain relief during molluscum contagiosum removal in children including those younger than 4 years.
