Abstract
We investigated the safety and effectiveness of routine benzoyl peroxide gel (Bepio(R) Gel 2.5%; hereinafter, this preparation) use in patients with acne vulgaris based on the 3-month interim results of this study.
Adverse drug reactions developed in 57 (15.1%) of the total 378 cases, but no reactions were serious. Adverse drug reactions at the application site (erythema, irritation, dryness, pruritus, skin exfoliation, and pain) usually developed within the first month of use. The onset rate of skin irritation symptoms showed no tendencies for sex, age, or severity of acne vulgaris, but was significantly higher in patients with sensitive skin types. Contact dermatitis developed in 5 cases, namely after 5 to 20 days of use of this preparation.
The (median) reduction rate in the total number of facial skin lesions after 3 months of use of this preparation was 75.0% for inflammatory, 61.3% for non-inflammatory, and 67.7% for total skin lesion count. Good results were also obtained in pediatric patients under 12 years of age, and inflammatory skin lesion reduction was particularly significant compared to patients of 12 years and older. Concerning overall improvement, “markedly improved” and “improved” were judged in 271 (73.4%) of 377 cases for facial lesions, and 18 (58.1%) of 32 cases for nonfacial lesions. Evaluation of quality of life using the Japanese version of Skindex-16 showed improvement in all of the symptom, emotion, function, and total scores after 3 months of use of this preparation.
Based on the above, this preparation seems to be a useful option for the treatment of acute inflammatory acne vulgaris, as well as for pediatric patients and acne lesions on the trunk.
