Efficacy and safety of a new once-daily topical ketoconazole 2% gel in the treatment of seborrheic dermatitis: a phase III trial

J Drugs Dermatol. 2006 Jul-Aug;5(7):646-50.


Background: The first gel formulation of ketoconazole has been tested in 2-week treatment courses.

Objective: To evaluate the efficacy and safety of a new, once-daily, 2-week ketoconazole 2% gel treatment in moderate to severe seborrheic dermatitis.

Methods: Four hundred fifty-nine subjects with moderate to severe seborrheic dermatitis were randomized to receive ketoconazole 2% gel or vehicle gel once daily for 14 days. The primary efficacy was the proportion of successfully treated subjects at day 28 (cleared and almost cleared).

Results: A significantly greater percentage of subjects were successfully treated with ketoconazole 2% gel compared with vehicle (25.3% vs. 13.9%, P = .0014). Ketoconazole 2% gel improved erythema, scaling (P = .0022 vs. vehicle), and pruritus. Mean overall symptom severity was reduced by 53% and 39% with ketoconazole gel and vehicle, respectively. Adverse events were few, generally mild or moderate, and similar between treatment groups.

Conclusion: Once-daily ketoconazole 2% gel is an effective,well-tolerated, convenient, and cosmetically acceptable treatment for moderate to severe seborrheic dermatitis.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / therapeutic use
  • Dermatitis, Seborrheic / drug therapy*
  • Female
  • Gels
  • Humans
  • Ketoconazole / administration & dosage
  • Ketoconazole / therapeutic use*
  • Male
  • Middle Aged
  • Safety
  • Treatment Outcome


  • Antifungal Agents
  • Gels
  • Ketoconazole