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Background: Pityriasis (tinea) versicolor has a high Main Outcome Measures: Mycological cure rates at
tendency to recur after being treated successfully. Pro- the end of open treatment and at the end of prophylac-
phylactic treatment to reduce recurrence is needed. tic treatment.
Objective: To determine whether recurrence of pity- Results: Mycological cure at the end of open treatment
riasis versicolor could be prevented by prophylactic was 92% (205/223). At the prophylactic treatment end point
itraconazole treatment. (6 months), mycological cure was 88% (90/102) in the itra-
conazole group and 57% (56/99) in the placebo group
Design: Open treatment followed by a randomized, (P.001). In open treatment, 11 patients were not able
double-blind, placebo-controlled phase. to be evaluated for efficacy. In prophylactic treatment, 4
patients in the itraconazole group and 4 in the placebo
Setting: Multinational outpatient centers. group were not able to be evaluated. Adverse events were
reported during open treatment by 26 patients (11%) and
Patients: A total of 239 consecutive patients were in- during prophylactic treatment by 17 (16%) in the itra-
cluded; 238 started open treatment. A total of 209 pa- conazole group and 14 (14%) in the placebo group. No
tients started prophylactic treatment: 106 in the itra- patients experienced any serious adverse events.
conazole group and 103 in the placebo group.
Conclusions: Prophylactic itraconazole treatment is ef-
Interventions: Open treatment: itraconazole, 200 mg ficacious for pityriasis versicolor after 6 months, as is
once daily for 7 days. Prophylactic treatment: itracona- itraconazole in the treatment of pityriasis versicolor.
zole, 200 mg, or placebo twice daily 1 day per month for
6 consecutive months. Arch Dermatol. 2002;138:69-73
P
ITYRIASIS (TINEA) versicolor mulative dose of at least 1000 mg being re-
From the Department of may be treated with topical or quired for effective therapy.6,7 Four weeks
Dermatology, Sahlgrenska oral agents, with the latter after the start of therapy, cure rates of 80%
University Hospital, being used especially when to 90% have been reported.7 Although the
Gothenburg, Sweden the disease is widespread or fungal organisms may be nonviable, the
(Dr Faergemann); the Division does not respond to topical measures. Sys- color of the affected skin may take several
of Dermatology, Department of temic agents used for treating pityriasis ver- weeks or months to normalize.
Medicine, Sunnybrook and sicolor include itraconazole, ketocona- Pityriasis versicolor recurs at a vari-
Womens College, Health
zole, and fluconazole.1,2 able rate in treated individuals, and 60%
Sciences Center, Sunnybrook,
and the University of Toronto, Itraconazole is a triazole antimycotic to 90% of patients relapse within 2 years
Toronto, Ontario (Dr Gupta); agent with strong keratophilic and lipo- in some series.8 Therefore, it is important
the Division of Dermatology, philic properties.3 Similar to other azole an- to evaluate a prophylactic regimen that
King Fahad National Guard tifungal agents, the mode of action of itra- may be effective and safe in preventing the
Hospital, Riyadh, Saudi Arabia conazole involves inhibition of 14-- recurrence of pityriasis versicolor.
(Dr Al Mofadi); the demethylase, resulting in impaired sterol We evaluated the efficacy of treat-
Departments of Dermatology, synthesis in fungal cell membranes. In vitro, ment with itraconazole, 200 mg once daily
Riyadh Armed Forces Hospital, itraconazole is active not only against yeasts for 1 week, and the efficacy of placebo-
Riyadh (Dr Abanami) and
such as Malassezia and Candida species but controlled prophylactic treatment with
Mafraque Hospital, Ministry of
Health, Abu Dubai, United also against dermatophytes and nonder- itraconazole, 200 mg taken 12 hours apart
Arab Emirates (Dr Abu matophyte molds.4,5 1 day per month for 6 consecutive months,
Shareaah); and Medisearch When itraconazole is used to treat in terms of clinical and mycological out-
International, Mechelen, pityriasis versicolor, a suggested regimen come and frequency of recurrence of pity-
Belgium (Dr Marynissen). is 200 mg/d for 7 days, with a minimum cu- riasis versicolor. To our knowledge, this
is the first study to evaluate this regimen of itracona- Twenty-nine patients who received treatment in the
zole as a prophylactic measure against pityriasis versi- open phase did not continue into the double-blind pro-
color. phylactic phase. Of these, 18 were not cured and 11 were
lost to follow-up or were noncompliant. At the end of open
RESULTS treatment, mycological cure was recorded in 205 (92%) of
223 patients (Table 2). All patients randomized into the
PATIENT DISPOSITION double-blind prophylactic phase were mycologically nega-
tive at the time of randomization. At the end of the pro-
There were 239 patients recruited. One patient with- phylactic phase, 90 (88%) of 102 patients in the itracona-
drew consent and received no treatment. Therefore, 238 zole group and 56 (57%) of 99 in the placebo group were
patients entered the open treatment phase and received still mycologically negative (P.001) (Table 2).
itraconazole, 200 mg/d for 7 days. Demographic and other
baseline characteristics of the patients are given in CLINICAL GLOBAL EVALUATION
Table 1. Data are presented on an on-protocol basis (ie,
having excluded patients who were characterized as hav- Findings were scored as cured, marked improvement, mod-
ing a major protocol deviation). erate improvement, unchanged, or deteriorated. Global
evaluation scores were significantly better in the itracona- tients during the open treatment phase and in 2 in the
zole group compared with the placebo group when evalu- itraconazole group during the prophylactic treatment
ated at the prophylactic treatment end point (P.001). For phase. All these adverse events were mild to moderate
all variables (erythema, hypopigmentation, desquama- in intensity, except for severe pruritus in 1 patient. All
tion, and itching), the itraconazole group showed signifi- patients continued in the trial except for 1 in open treat-
cantly superior changes at the prophylactic treatment end ment who experienced urticaria and was withdrawn. Two
point compared with the placebo group. patients in open treatment and 4 in the placebo group of
prophylactic treatment were withdrawn from the trial be-
ADVERSE EVENTS cause of adverse events. Moderate urticaria in 1 patient
was the only adverse event leading to withdrawal that was
Adverse events were reported by 26 patients (11%) dur- considered to be very likely related to trial medication
ing open treatment and 31 (15%) during prophylactic use. No patients experienced a severe adverse event.
treatment (17 patients [16%] in the itraconazole group The most common adverse events during open treat-
and 14 [14%] in the placebo group). ment were gastrointestinal tract complaints, which were
Adverse events considered to be possibly, prob- reported by 9 patients (4%). There were no reports of gas-
ably, or very likely drug related were reported in 10 pa- trointestinal tract complaints during prophylactic treat-