A multicentre, randomized, double-blind, comparative, vehicle-controlled study was conducted to compare the efficacy and safety of fluocinolone acetonide (FA) shampoo 0.01% (FS Shampoo) with its vehicle (shampoo base) for the treatment of seborrhoeic dermatitis of the scalp in 100 patients. Efficacy was based on improvement in erythema, scaling and pruritus (using a scale of 3 = severe to 0 = cleared). On day 14 of treatment, erythema in patients treated with FA shampoo had improved by 72 to 86% and in those treated with the vehicle the erythema had improved by 34 to 52% (P < 0.001). Scaling had improved by 65 to 85% in patients treated with FA shampoo, and in patients treated with the vehicle scaling had improved by 36 to 51% (P < 0.001). Pruritus in patients treated with FA shampoo had improved by 70 to 92%, and in those treated with the vehicle pruritus had improved by only 30 to 40%. (P = 0.004). Physicians' global assessments showed, after 14 days of treatment, that 84% of FA shampoo-treated patients...