Abstract | BACKGROUND:
Pityriasis ( tinea) versicolor has a high tendency to recur after being treated successfully. Prophylactic treatment to reduce recurrence is needed. OBJECTIVE: DESIGN: Open treatment followed by a randomized, double-blind, placebo-controlled phase. SETTING: Multinational outpatient centers. PATIENTS: A total of 239 consecutive patients were included; 238 started open treatment. A total of 209 patients started prophylactic treatment: 106 in the itraconazole group and 103 in the placebo group. INTERVENTIONS: Open treatment: itraconazole, 200 mg once daily for 7 days. Prophylactic treatment: itraconazole, 200 mg, or placebo twice daily 1 day per month for 6 consecutive months. MAIN OUTCOME MEASURES: Mycological cure rates at the end of open treatment and at the end of prophylactic treatment. RESULTS: Mycological cure at the end of open treatment was 92% (205/223). At the prophylactic treatment end point (6 months), mycological cure was 88% (90/102) in the itraconazole group and 57% (56/99) in the placebo group (P<.001). In open treatment, 11 patients were not able to be evaluated for efficacy. In prophylactic treatment, 4 patients in the itraconazole group and 4 in the placebo group were not able to be evaluated. Adverse events were reported during open treatment by 26 patients (11%) and during prophylactic treatment by 17 (16%) in the itraconazole group and 14 (14%) in the placebo group. No patients experienced any serious adverse events. CONCLUSIONS:
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Authors | Jan Faergemann, A K Gupta, A Al Mofadi, A Abanami, A Abu Shareaah, Greet Marynissen |
Journal | Archives of dermatology
(Arch Dermatol)
Vol. 138
Issue 1
Pg. 69-73
(Jan 2002)
ISSN: 0003-987X [Print] United States |
PMID | 11790169
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adolescent
- Adult
- Aged
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Itraconazole
(administration & dosage)
- Male
- Middle Aged
- Sensitivity and Specificity
- Tinea Versicolor
(drug therapy, pathology)
- Treatment Outcome
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