Treatment and Prophylaxis of Seborrheic Dermatitis of the Scalp with Antipityrosporal 1% Ciclopirox Shampoo
Shuster S, et al. Archives of Dermatology. 2005;141:47-52.
The authors present a double-blinded, randomized, vehicle-controlled, multicenter study to evaluate the safety and efficacy of ciclopirox shampoo in regards to treatment and prophylaxis of seborrheic dermatitis of the scalp. One thousand patients were enrolled using a 6-point scale to rate their seborrheic dermatitis. Inclusion required a rating of at least moderate. After a 4-week washout period, 949 patients used an open-label shampoo (Prell) twice weekly for 2 weeks. The study was then divided into 2 segments. During Segment A, patients were enrolled to one of 3 treatment arms: ciclopirox shampoo once weekly, twice weekly, or vehicle in a 2:2:1 ratio. Blinding was maintained by giving all patients 2 bottles of shampoo and requiring use of each bottle once weekly. Thus patients received 2 bottles of ciclopirox, 2 of vehicle, or 1 of each depending on the treatment arm. Segment A lasted 4 weeks. Afterwards, patients were evaluated for both primary and secondary outcomes. The primary outcome was defined as "effectively treated," which consisted of a rating of 0 (or 1 if baseline score was [greater than or equal to]3) for the following parameters: inflammation, scaling, and status of seborrheic dermatitis. The secondary outcome was defined as "cleared," which was determined in the same manner as the primary outcome with the additional rating of itching. Those patients deemed responders (428 in total) were then randomized to 1 of 3 treatment arms in a 1:1:1 ratio for Segment B, ciclopirox once weekly, once every 2 weeks, or vehicle. The objective of Segment B was to assess prophylaxis. Segment B lasted 12 weeks at which time patients were again blindly evaluated. The primary outcome for Segment B was "relapse rate," defined as an increase in score from the beginning of Segment B by 2 or more. Results demonstrated a dose-dependent effect for ciclopirox compared with vehicle both in the treatment and prophylaxis of seborrheic dermatitis of the scalp. Response rates were 57.9% for ciclopirox twice weekly, 45.4% for ciclopirox once weekly, and 31.6% for vehicle. Relapse rates were 14.7% for ciclopirox once weekly, 22.1% for ciclopirox once every 2 weeks, and 35.5% for vehicle. Both the response and the relapse rates showed a statistically significant difference between ciclopirox and vehicle. The study drug was also very well-tolerated with no evidence of serious adverse events.
This was a well-designed study done to provide more convincing data regarding the efficacy of ciclopirox in the treatment of seborrheic dermatitis of the scalp compared with prior smaller studies. The efficacy of ciclopirox as prophylaxis was also an objective, as this had not yet been studied directly. The study was adequately powered and statistically significant differences were achieved between ciclopirox and vehicle in both segments. The authors comment that roughly 60% of patients in Segment A had prior treatments, most commonly an anti-fungal. It is possible that response rates may be higher in the general population as some patients in this study may have had recalcitrant disease.
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