Clinical efficacies of shampoos containing ciclopirox olamine (1.5%) and ketoconazole (2.0%) in the treatment of seborrhoeic dermatitis.
BACKGROUND
Ciclopirox olamine (CPO) is a broad-spectrum antifungal with anti-inflammatory properties effective against the yeast implicated in seborrhoeic dermatitis, Malassezia spp. This study compared 1.5% CPO shampoo with 2.0% ketoconazole shampoo and placebo in scalp seborrhoeic dermatitis.


METHODS
A randomized, double-blind, 4-week treatment period was preceded by a 2-week run-in period and followed by a 2-week run-out period. A total of 350 patients (150 CPO, 150 ketoconazole, 50 placebo) were enrolled. Assessments included scalp area affected, the severity of scaling, erythema, itching and scaling, and overall signs and symptoms.


RESULTS
Both shampoos were significantly more effective than placebo in reducing the area affected. The mean reduction from baseline to end of treatment was 48.2 cm(2) with CPO, 41.4 cm(2) with ketoconazole and 20.0 cm(2) with placebo. Patients rated the CPO shampoo as superior to placebo (p<0.001) and ketoconazole shampoo (p<0.05) on the basis of overall signs and symptoms. Assessments of itching and scaling were also significantly in favour of the CPO shampoo over placebo at the end of treatment. All three shampoos were well tolerated.


CONCLUSIONS
CPO shampoo was superior to placebo and at least as effective as ketoconazole shampoo in treating scalp seborrhoeic dermatitis. Patients rated the overall improvement as better with CPO than with ketoconazole shampoo.
Ratnavel
Ravi C
RC
Department of Dermatology, Stoke Mandeville NHS Trust, Aylesbury, UK.
Squire
Ruth A
RA
Boorman
Graham C
GC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D000077768:Ciclopirox; D012628:Dermatitis, Seborrheic / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D006203:Hair Preparations; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D011728:Pyridones / Q000008:administration & dosage / Q000627:therapeutic use*; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000935:Antifungal Agents; D006203:Hair Preparations; D011728:Pyridones; D000077768:Ciclopirox; D007654:Ketoconazole