OBJECTIVES:Nadifloxacin is a fluoroquinolone with broad-spectrum antibacterial activity. Although it is used as an acne treatment in some European countries, it has not been used to treat Korean acne patients. We aimed to evaluate the clinical efficacy and safety of 1% nadifloxacin cream and the histological changes it incurs when used to treat mild to moderate facial acne in Korean patients. METHODS: An eight-week, randomized, prospective, split-face, double-blind, vehicle-controlled trial was performed. All participants were treated with 1% nadifloxacin cream on one-half of the face and vehicle cream on the other, twice per day for eight weeks. RESULTS: At final visits, inflammatory acne lesions were reduced by 70% on nadifloxacin-treated skin and increased by 13.5% on vehicle-treated skin; non-inflammatory acne lesions showed reductions of 48.1 and 10.1%, respectively. A significant difference was observed between the two treatments at four weeks. Histopathological examinations of the acne lesions showed decreased inflammation and interleukin-8 expression but no change in transforming growth factor-β expression in nadifloxacin-treated skin compared with vehicle-treated skin after eight weeks of treatment. CONCLUSIONS:Nadifloxacin 1% cream is an effective, safe, and well-tolerated topical treatment for Korean patients with mild to moderate acne vulgaris. Histopathological changes after nadifloxacin treatment were well correlated with clinical outcomes. Therefore, nadifloxacin can be used as an effective and safe treatment option in the management of mild to moderate acne in Asian subjects.
RCT Entities:
OBJECTIVES:Nadifloxacin is a fluoroquinolone with broad-spectrum antibacterial activity. Although it is used as an acne treatment in some European countries, it has not been used to treat Korean acnepatients. We aimed to evaluate the clinical efficacy and safety of 1% nadifloxacin cream and the histological changes it incurs when used to treat mild to moderate facial acne in Korean patients. METHODS: An eight-week, randomized, prospective, split-face, double-blind, vehicle-controlled trial was performed. All participants were treated with 1% nadifloxacin cream on one-half of the face and vehicle cream on the other, twice per day for eight weeks. RESULTS: At final visits, inflammatory acne lesions were reduced by 70% on nadifloxacin-treated skin and increased by 13.5% on vehicle-treated skin; non-inflammatory acne lesions showed reductions of 48.1 and 10.1%, respectively. A significant difference was observed between the two treatments at four weeks. Histopathological examinations of the acne lesions showed decreased inflammation and interleukin-8 expression but no change in transforming growth factor-β expression in nadifloxacin-treated skin compared with vehicle-treated skin after eight weeks of treatment. CONCLUSIONS:Nadifloxacin 1% cream is an effective, safe, and well-tolerated topical treatment for Korean patients with mild to moderate acne vulgaris. Histopathological changes after nadifloxacin treatment were well correlated with clinical outcomes. Therefore, nadifloxacin can be used as an effective and safe treatment option in the management of mild to moderate acne in Asian subjects.