SAN FRANCISCO, CA -- March 25, 2003 -- A shampoo containing 1% ciclopirax has demonstrated safety and efficacy for the treatment of seborrhoeic dermatitis of the scalp, according to a phase III, multi-national trial.

Researchers, led by Sam Shuster, MD, from Framlingham, Suffolk, England, randomised 949 patients with moderate seborrhoeic dermatitis of the scalp in a 2:2:1 fashion to treatment with a 1% ciclopirax shampoo once weekly, 1% ciclopirax shampoo twice weekly or the same shampoo vehicle without the active ingredient. Dr. Shuster presented the results in a poster here on March 22^nd at the 61^st Annual Meeting of the American Academy of Dermatology.

Prior to starting the study drug, patients had a two week run-in phase with a cosmetic shampoo, which was used at least twice weekly. During the study, they used approximately 5 mL of the medicated shampoo per application if their hair was above shoulder-length and about 10 mL per application if it was greater than shoulder length.

Based on an intent-to-treat analysis, after four weeks of treatment, response rates, as assessed by global response rate using a 6-point scale and change from baseline were superior in both patient groups using the active ingredient, compared with the vehicle group (p<0.001 for both).

Overall, 58.5% of patients using the ciclopirax shampoo responded to the medication, compared with 45.5% in the once weekly group and 31.6% in the vehicle group. A statistically greater number of patients in both active treatment groups cleared, compared with those in the vehicle group (p=0.001 for the twice a week and p=0.037 for the once a week group, compared with placebo).

Adverse events associated with the treatment were primarily cutaneous and mild, and their prevalence was the same for the active treatment and vehicle groups.

Based on these findings, the authors concluded that treatment with a 1% ciclopirax shampoo is a safe, effective and well-tolerated treatment for seborrhoeic dermatitis of the scalp.

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