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Year : 1999  |  Volume : 65  |  Issue : 3  |  Page : 151-152

Single dose itraconazole therapy in tinea versicolor; a double blind, randomised placebo controlled study

Correspondence Address:
B C Ravikumar

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Source of Support: None, Conflict of Interest: None

PMID: 20921642

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How to cite this article:
Ravikumar B C, Balachandran C, Sabitha L. Single dose itraconazole therapy in tinea versicolor; a double blind, randomised placebo controlled study. Indian J Dermatol Venereol Leprol 1999;65:151-2

How to cite this URL:
Ravikumar B C, Balachandran C, Sabitha L. Single dose itraconazole therapy in tinea versicolor; a double blind, randomised placebo controlled study. Indian J Dermatol Venereol Leprol [serial online] 1999 [cited 2019 Oct 14];65:151-2. Available from: http://www.ijdvl.com/text.asp?1999/65/3/151/4795

  To the Editor, Top

There are numerous agents available for the treatment of Tinea versicolor (TV) with variable efficacy and which require lengthy treatment periods.[1] Fluconazole and itraconazole are the new oral triazole derivatives which are an improvement over the short comings of other existing drugs.[2]

Various short course regimens are available to treat TV. However, an ideal treatment regimen would be a low dose of the drug given for a very short period.[3] Itraconazole has been used successfully in TV in regime of, 100 mg daily for 15 days or 200 mg daily for 5 days.[3] Fluconazole is effective even with a single dose of 400 mg.[4] In this regard we conducted a randomised, double blind placebo controlled study with a single dose of 400 mgs of itraconazole. Twenty-five patients of Tinea versicolor who were KOH smear positive and who had more than 10% of body involvement were recruited in the study. Twelve of them received 4 capsules of itraconazole of l00 mgs each as a single dose and the other 13 patients received 4 similarly looking placebo capsules. All the samples were coded and labelled randomly from A...to Z by a pharmacist. The patients were assessed every 2 weeks clinically and by KOH smear up to a total of 8 weeks. The clinical assessment included grading of hypo/hyper pigmentation, scaling and itching on a severity scale of 0 to 3.

When the decoding was done, it was found that out of 13 patients treated with itraconazole, 2 patients improved clinically and mycologically by 8 weeks, and same number of patients improved in the placebo group. None of the patients in either group had any side effects.

Though the minimum inhibitory concentration of itraconazole invitro is 0.1 ug/ml[5] and the drug persists in the skin for more than 3 to 4 weeks after cessation of therapy,[6] it is clear from this study that a single high dose of 400 mg of itraconazole is ineffective in the treatment of TV and this finding supports the existing view that a minimum total dose of 1000 mgs of itraconazole given for at least 5 days is necessary to treat Tinea versicolor.[3]

  Acknowledgement Top

We thank Glenmark Pharmaceuticals Ltd who supplied Itraconazole (Canditral) capsules to conduct this study. We also thank Mr. Deshpande, the pharmacist who helped in preparing the coded itraconazole and placebo capsules.

  References Top

1.Hay RJ. Treatment of superficial fungal infections. Clin Exp Dermatol 1981;6:509-513.  Back to cited text no. 1  [PUBMED]  [FULLTEXT]
2.Cutsem VJ, Gerven VF, Janssen PAJ. The antifungal activity of azoles: in vitro and in vivo activity. 9th Congress of the National Society for Human and Animal Mycology. Atlanta, Ga: May 19-24, 1985:3-23.  Back to cited text no. 2    
3.Delescluse J. Itraconazole in tinea versicolor: a review. J Am Acad Dermatol 1990;23:551-554.  Back to cited text no. 3  [PUBMED]  [FULLTEXT]
4.Faergemann J. Treatment of pityriasis versicolor with a single dose of fluconazole. Acta Derm Venereol (Stockh) 1992;72:74-75.  Back to cited text no. 4  [PUBMED]  [FULLTEXT]
5.Cutsen VJ, Gerven VF, Janessen PAJ. The in vitro and in vivo antifungal activity of itraconazole. In: Fromtling RA, ed. Recent Trends in the Discovery, Development and Evaluation of Antifungal Agents. JR Prous Science Publishers SA, 1987:177-192.  Back to cited text no. 5    
6.Cauwenbergh G, Degreef H, Heykants J, et al. Pharmacokinetic profile of orally administered itraconazole in human skin. J Am Acad Dermatol 1988;18:263-268.  Back to cited text no. 6  [PUBMED]  [FULLTEXT]


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