Benzoyl peroxide gel (Bepio^® Gel 2.5%, hereinafter, BPO) that has antibacterial activity and exfoliating action was approved for the treatment of acne vulgaris in December 2014. The safety and efficacy were evaluated in the Special Drug Use-Results Survey starting in July 2015 with a 12-month observation period for acne vulgaris in clinical practice. Adverse drug reactions were observed in 15.2% (169/1109) in the safety analysis set. Application site erythema was observed in 1 patient as serious, but the other events were non-serious. All of the 169 patients experienced skin irritation symptoms which is an important identified risk in the Risk Management Plan, and 119 of these patients experienced skin irritation symptoms within 1 month of the start of the administration. The incidence proportion of skin irritation symptoms tended to be higher in women and in patients with dry or sensitive skin, but the specific patient group that should avoid the drug use was not identified. The number of facial skin lesions were reduced by a median of 80.0% for inflammatory, 66.7% for non-inflammatory, and 73.9% for total skin lesion count at the final evaluation within 12 months. With regard to overall improvement at the final evaluation, “markedly improved” and “improved” accounted for 71.4% (788/1103) of facial lesions and 64.1% (59/92) of non-facial lesions. Evaluation of quality of life using the Japanese version of Skindex-16 showed a significant reduction in all of the symptoms, emotion, function, and total scores after 3 months of use of BPO versus baseline, and the reduction was maintained at 12 months following the use of BPO. These results indicate that BPO is useful not only in the acute inflammatory phase, but also in long-term use in real clinical settings.

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We conducted a questionnaire survey to investigate the needs of patients with recurrent genital herpes (RGH) and actual clinical practice by doctors. The respondents comprised 232 patients with RGH and 231 doctors, including dermatologists, gynecologists/obstetricians, and urologists. Among patients who replied to the survey, the male/female ratio was 6:4, and 80% of the patients had 1–2 recurrences per year. While 60% of all patients used oral antiviral drugs alone or in combination with topical antiviral agents, 30% replied that they were treated with topical antiviral drugs (hereinafter, topical drugs) alone. The proportion of patients who rated the current treatment “satisfactory” was 44.6% for patient-initiated therapy (PIT), 31.1% for 5-day administration, 32.5% for suppressive therapy, and 17.6% for topical drugs alone. Among doctors who replied that they use viral antibody tests for diagnosis, more than half of the gynecologists/obstetricians or urologists replied that they perform antibody tests to determine the presence/absence of the virus in rashes at the patients’ visits. What patients and doctors considered important in RGH care differed greatly. The item that showed the largest difference was “prevention of recurrence” (38.8% in the patients and 16.9% in the doctors). The results of this survey showed that, although the main therapy was oral therapy recommended by practice guidelines by the Japanese Society for Sexually Transmitted Infections and other academic societies, a certain number of patients are treated with topical drugs alone, suggesting the possibility that the guidelines have not been adopted well. Treatment with oral antiviral drugs had higher patient satisfaction than that with topical drugs alone. Although preventing recurrence of RGH completely is difficult, it is desirable to provide basically oral treatments with which patients can handle recurrence proactively, and to instruct patients with consideration of their worries and wishes.

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