A randomized, double-blind, placebo-controlled trial of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo in the treatment of moderate to severe dandruff.
BACKGROUND
Ketoconazole is highly effective against the yeast Pityrosporum ovale, an organism believed to be involved in the pathogenesis of dandruff.


OBJECTIVE
Our purpose was to evaluate the safety and effectiveness of ketoconazole 2% shampoo versus selenium sulfide 2.5% shampoo and placebo shampoo in patients with moderate to severe dandruff.


METHODS
Features assessed included adherent and loose dandruff scores, presence or absence of irritation, itching, yeast cells, and global improvement rating by the investigator.


RESULTS
A total of 246 patients were included. Mean total adherent dandruff score declined throughout the treatment period with both ketoconazole 2% and selenium sulfide 2.5% shampoos significantly better than placebo at all visits. Ketoconazole was statistically superior to selenium sulfide at day 8 only (p = 0.0026). Both medicated shampoos were significantly better than placebo for reducing irritation and itching. Of the nine adverse experiences reported during the treatment phase, all involved patients treated with selenium sulfide 2.5% shampoo.


CONCLUSIONS
Both ketoconazole 2% shampoo and selenium sulfide 2.5% shampoo are effective in the treatment of moderate to severe dandruff; however, ketoconazole 2% shampoo appears to be better tolerated.
Danby
F W
FW
Division of Dermatology, Queen's University, Kingston, Ontario, Canada.
Maddin
W S
WS
Margesson
L J
LJ
Rosenthal
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D012628:Dermatitis, Seborrheic / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D006203:Hair Preparations; D006801:Humans; D007654:Ketoconazole / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012536:Scalp Dermatoses / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D018036:Selenium Compounds / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012915:Soaps; D013997:Time Factors; D016896:Treatment Outcome
D006203:Hair Preparations; D018036:Selenium Compounds; D012915:Soaps; D007654:Ketoconazole; C025698:selenium disulfide