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

J Am Acad Dermatol. 1993 Dec;29(6):1008-12. doi: 10.1016/0190-9622(93)70282-x.


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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Child
  • Child, Preschool
  • Dermatitis, Seborrheic / complications
  • Dermatitis, Seborrheic / drug therapy*
  • Dermatitis, Seborrheic / microbiology
  • Double-Blind Method
  • Female
  • Hair Preparations
  • Humans
  • Ketoconazole / therapeutic use*
  • Male
  • Middle Aged
  • Scalp Dermatoses / complications
  • Scalp Dermatoses / drug therapy*
  • Scalp Dermatoses / microbiology
  • Selenium Compounds / therapeutic use*
  • Severity of Illness Index
  • Soaps*
  • Time Factors
  • Treatment Outcome


  • Hair Preparations
  • Selenium Compounds
  • Soaps
  • Ketoconazole
  • selenium disulfide