Successful treatment and prophylaxis of scalp seborrhoeic dermatitis and dandruff with 2% ketoconazole shampoo: results of a multicentre, double-blind, placebo-controlled trial.

Pityrosporum ovale appears to play an important role in the pathogenesis of seborrhoeic dermatitis. Ketoconazole is an antimycotic agent with a high in vitro and in vivo efficacy against P. ovale. We performed a multicentre study to investigate the efficacy of ketoconazole 2% shampoo in the treatment and prophylaxis of seborrhoeic dermatitis and dandruff. Five hundred and seventy-five patients presenting with moderate to severe seborrhoeic dermatitis and dandruff of the scalp were treated with 2% ketoconazole shampoo twice weekly for 2-4 weeks, producing an excellent response in 88%. Of those patients who responded, 312 were included in a prophylactic phase, lasting 6 months. These patients were treated with the active preparation (shampoo containing 2% ketoconazole) once-weekly, once every other week, alternating with placebo (shampoo without ketoconazole), or with placebo only once-weekly. Forty-eight (47%) patients in the placebo group experienced a relapse of seborrhoeic dermatitis, compared with 23 (19%) patients in the active treatment group, and 31 (31%) patients in the active/placebo group. The medication was well tolerated in all three groups. We conclude that ketoconazole 2% shampoo is highly effective, not only in clearing scalp seborrhoeic dermatitis and dandruff, but also in preventing relapse of the disease when used prophylactically once weekly.

Levocabastine nasal spray better than sodium cromoglycate and placebo in the topical treatment of seasonal allergic rhinitis.

The efficacy and safety of the nasal administration (twice in each nostril, four times a day) of levocabastine (0.5 mg/ml) were compared with those of sodium cromoglycate (20 mg/ml) and placebo in a 2-week, parallel, double-blind trial in patients with seasonal allergic rhinitis. At the end of treatment, 89% of patients in the levocabastine-treated group rated their treatment as globally good or excellent as compared with 32% (p = 0.003) of sodium cromoglycate-treated and 35% (p = 0.002) of placebo-treated patients. According to the investigators' ratings, the severest nasal symptom and ocular complaints responded better to levocabastine than to cromoglycate (p = 0.05 and p = 0.03) or placebo treatment (p = 0.03 and p = 0.001). Visual analogue scale ratings in patients' diaries indicated that at the end of therapy, nasal symptoms were less severe in the levocabastine-treated group than in the sodium cromoglycate-treated (p = 0.03) or placebo-treated group (p = 0.001). Total symptom severity as a percentage of the theoretical maximum symptom severity during the treatment period was lower for levocabastine than for sodium cromoglycate (p = 0.06) or placebo (p = 0.004) for the severest nasal symptom (35% versus 47% and 76%), sneezing (the most frequent symptom) (27% versus 42% and 67%), and itchy nose (18% versus 37% and 67%). The percentage of days at which nasal symptoms were entirely absent was markedly higher in the levocabastine-treated (33%) than in the sodium cromoglycate-treated (9%; p = 0.006) or placebo-treated (3%; p = 0.001) group.(ABSTRACT TRUNCATED AT 250 WORDS)