Treatment of mild to moderate seborrhoeic dermatitis of the face with Sebclair®: results of a multicentre, controlled, randomized, double-blind study

Sebclair (R) is a steroid-free cream approved in Europe as class IIa medical device for the treatment of seborrhoeic dermatitis (SD). Objective of this study was to evaluate the efficacy and safety of Sebclair (R) in the treatment of adult patients with mild to moderate SD on the face. Sixty patients were randomized to receive Sebclair (R) (n=40) or a vehicle (n=20). The primary endpoint was investigators' global assessment (IGA) score at day 28, compared with baseline. Secondary endpoints included: IGA score at day 14; investigators' assessment of erythema and scaling; patients' assessment of burning/stinging, pruritus and global response; quality of life. A higher percentage of success was observed in the Sebclair (R) group than in the vehicle group (68% vs 11%, P < 0.0001). The effects of Sebclair (R) were significantly better than those of vehicle for investigators'- assessed erythema and scaling, and patients'-assessed pruritus and global response to Sebclair (R) (P <= 0.01). Four patients (two each in the Sebclair (R) and vehicle group) reported non-serious adverse events. Sebclair (R) appears to be an effective and well tolerated cream for the treatment of adult patients with mild to moderate SD on the face.