Ketoconazole gel 2% in the treatment of moderate to severe seborrheic dermatitis.

Seborrheic dermatitis traditionally has been treated with topical steroids. In current practice, however, antifungal agents such as ketoconazole often are used because Malassezia yeasts are thought to play a role in the disease pathogenesis. Ketoconazole gel 2% has been developed for the once-daily treatment of seborrheic dermatitis. This gel is almost invisible after application, unlike ketoconazole cream, and may offer advantages in patient acceptance and adherence to treatment. Three randomized, double-blinded, vehicle-controlled, multicenter, parallel-group phase 3 studies evaluated the efficacy and tolerability of ketoconazole gel 2% compared with a vehicle gel in more than 900 subjects with moderate to severe seborrheic dermatitis who applied treatment for 14 days and were followed for an additional 14 days. Two of these studies also compared a combination gel containing ketoconazole 2% and desonide 0.05%, each active gel individually, and a vehicle control. Subjects were considered effectively treated if the erythema and scaling as well as investigator global assessment (IGA) scores decreased to 0 (or 1 if the baseline score was > or =3) by day 28. Pooled data from these studies showed that the proportion of effectively treated subjects was significantly greater in the ketoconazole gel 2% treatment group compared with the vehicle group (P < .001). The comparison of the combination gel to its individual components revealed that the efficacy of ketoconazole alone was comparable to the combination gel as well as desonide gel alone for up to 2 weeks after the end of treatment. These data suggest that once-daily ketoconazole gel 2% is an effective treatment for seborrheic dermatitis and a viable alternative to the ketoconazole cream 2% formulation.

Clobetasol propionate lotion in the treatment of moderate to severe plaque-type psoriasis.

Owing to its anti-inflammatory, antipruritic, vasoconstrictive, and immune-modulating properties, clobetasol propionate is used to treat psoriasis. This study was conducted to evaluate the efficacy, safety, and cosmetic acceptability of clobetasol propionate lotion compared with its vehicle and with clobetasol propionate cream in the treatment of moderate to severe plaque-type psoriasis. A total of 222 patients were treated. After 4 weeks of treatment, clobetasol propionate lotion was more efficient than vehicle lotion and of equivalent efficacy as clobetasol propionate cream. Cosmetic acceptability was significantly better with clobetasol propionate lotion than with clobetasol propionate cream. Clobetasol propionate lotion was efficient, safe, and well tolerated and offers a significantly higher cosmetic advantage in the treatment of moderate to severe plaque-type psoriasis compared with clobetasol propionate cream.

A multicenter randomized trial of ketoconazole 2% and zinc pyrithione 1% shampoos in severe dandruff and seborrheic dermatitis.

Ketoconazole (KET) and zinc pyrithione (ZPT) are compounds active against the Malassezia spp. yeasts, which are believed to play a major role in dandruff and seborrheic dermatitis. We compared the efficacy and safety of KET 2% and ZPT 1% in shampoo formulations for the alleviation of severe dandruff and seborrheic dermatitis. This open randomized, parallel-group trial began with a 2-week run-in phase during which subjects applied a neutral non-antidandruff shampoo. It was followed by a 4-week randomized treatment phase and a subsequent 4-week follow-up phase without treatment. Shampooing during the treatment period was carried out twice weekly for the KET group and at least twice weekly for the ZPT group in accordance with the label instructions. A total of 343 subjects were recruited to enter the trial. Of the 331 eligible volunteers, 171 were randomized to KET 2% and 160 to ZPT 1%. Clinical assessments were performed. Beneficial effects were evidenced for both medicated shampoos, but the effect was significantly better for KET 2%, which achieved a 73% improvement in the total dandruff severity score compared with 67% for ZPT 1% at week 4 (p < 0.02). The recurrence rate of the disease was also significantly lower following KET 2% treatment than following ZPT 1% treatment. As a consequence, the overall clearing of the skin condition at the end of treatment and follow-up phase was in favor of the KET 2% formulation (p = 0.004). Side effects were minimal. It is concluded that after a 4-week treatment, KET 2% shampoo was significantly superior to ZPT 1% shampoo in the treatment of subjects with severe dandruff or seborrheic dermatitis of the scalp. It is our assumption that this difference is noticeable for the patient and as a consequence relevant. Both formulations were well tolerated.