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


CONCLUSIONS
Once-daily ketoconazole 2% gel is an effective,well-tolerated, convenient, and cosmetically acceptable treatment for moderate to severe seborrheic dermatitis.
Elewski
Boni
B
University of Alabama at Birmingham, Birmingham, AL 35294, USA. beelewski@aol.com
Ling
Mark R
MR
Phillips
Tania J
TJ
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use; D012628:Dermatitis, Seborrheic / Q000188:drug therapy*; D005260:Female; D005782:Gels; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012449:Safety; D016896:Treatment Outcome
D000935:Antifungal Agents; D005782:Gels; D007654:Ketoconazole