Ds. Lange et al., Ketoconazole 2% shampoo in the treatment of tinea versicolor: A multicenter, randomized, double-blind, placebo-controlled trial, J AM ACAD D, 39(6), 1998, pp. 944-950
Background: Tinea versicolor is a common superficial fungal infection cause
d by a lipophilic yeast. This chronically recurring opportunistic infection
is especially prevalent in tropical and semitropical regions. The topical
short-term application of ketoconazole 2% shampoo may provide effective and
safe therapy for tinea versicolor.
Objective: The purpose of this study was to evaluate the efficacy and safet
y of a single application (1 day) versus three daily applications (3 days)
of ketoconazole 2% shampoo versus placebo shampoo in the treatment of mycol
ogically confirmed tinea versicolor.
Methods: Three hundred twelve patients were included in the primary analyse
s for this 31-day study. Global evaluation scores were measured on days 10
and 31 with a 5-point scale (1 = healed to 5 = worsening), and a cellophane
tape test was done at baseline and days 3, 10, and 31. Efficacy was assess
ed by clinical response, defined as both a global evaluation score of 1 (he
aled) and a negative cellophane tape test on day 31. Signs and symptoms of
tinea versicolor (scaling, itching, erythema, hypopigmentation, hyperpigmen
tation) also were evaluated at baseline, day 10, and day 31 with a 4-point
scale (0 = absent to 3 = severe).
Results: Both regimens of ketoconazole shampoo were significantly (P <.001)
more effective than placebo for rate of clinical response, global evaluati
on scores, and mycologic outcomes (cellophane tape test). The clinical resp
onse rates at day 31 were 73%, 69%, and 5% for the 3-day ketoconazole, 1-da
y ketoconazole, and placebo groups, respectively. The difference in the eff
icacy of the two ketoconazole treatment regimens was not statistically sign
ificant. There were no significant differences between any of the treatment
groups in the number of patients who experienced adverse events. No seriou
s adverse events occurred and no patient withdrew from the trial prematurel
y because of an adverse event.
Conclusion: Ketoconazole 2% shampoo, used as a single application or daily
for 3 days, is safe and highly effective in the treatment of tinea versicol
or.