Ketoconazole 2% shampoo in pityriasis versicolor: An open trial

Introduction

Pityriasis versicolor (PV) is a common superficial fungal infection of tropical and semitropical region. It is caused by the lipophilic yeast Malassezia furfur[1]. It is characterized by discrete or concrescent, scaly, discoloured or hypopigmented areas mainly on the upper trunk, proximal extremities and face[2]. The topical azole antifungal works well in PV. The main problem with the use of topical antifungals is the difficulty of applying creams to such a wide body surface area. A possible solution to this is provided by the development of a shampoo version of ketoconazole, and although it has not been fully evaluated in PV, two or three applications of the shampoo appear to clear most infections.[3] The efficacy of oral ketoconazole in PV is well documented.[4] The present study was conducted to evaluate the efficacy of ketoconazole 2% shampoo in the treatment of PV.

Materials and Methods

Thirty mycologically confirmed patients of pityriasis versicolor were included in the study. The signs and symptoms in the form of scaling, itching, erythema and hyperpigmentation were noted in each patient. Exclusion criteria included patients who had other skin problems, eye disease, use of systemic and/or topical corticosteroids and antifungals, preceding thirty days. The patients were asked to apply ketoconzole 2% shampoo, was left in place for 10 minutes and then rinsed thoroughly. All adverse events that occurred during the study were recorded. The patients were evaluated on first visit and after 30 days. On first visit skin scraping for KOH smear was done on each patient to establish the diagnosis mycologically. On day 30; the clinical signs and symptoms were noted and scraping was repeated..

Results

Thirty patients (all males) were enrolled in the study. Age ranged from 18 years to 32 years. Average duration of problem was five months (2 month - 1 year). In addition, 20 patients had mild-moderate dandruff on scalp. All the patients had hypopigmented lesions and scaling; 17 patients complained of mild itching which worsened after sweating. The lesions were distributed mainly on upper back, shoulders, neck and chest. No patients showed hyperpigmented lesions or erythema. After 30 days, itching and scaling subsided in all, while there was approximately 30-40% less in hyperpigmentation. KOH smear was negative in 27 patients. Two patients complained of mild irritation and pruritus after shampoo application on lesional sites, which lasted for half an hour and then subsided.

Discussion

Very few trials have been tried for ketoconazole 2% shampoo in PV. In earlier studies, ketoconazole 2% shampoo was shown to be highly effective and well tolerated for the treatment of PV, with significant reduction in scaling and elimination of the causative agent[5] Large et al[6] concluded that ketokonazole 2% shampoo, used as a single application or daily for 3 days, is safe and highly effective in the treatment of PV. This study also corroborates the same for three day application regimen. The advantage of shampoo is its ease of application, can be applied to larger area of involvement (unlike topical antifungals) and requires shorter duration of treatment. The treatment regimen was tolerated in this study, except two patients complained of pruitus and irritation but not upto the severity to stop the treatment. In this open trial the number of patients was less. Hence it would be interesting to explore further by comparing ketokonazole 2% shampoo with other treatment modalities in the treatment of PV, taking more number of patients. Further large controlled trials are required to establish its efficacy in pityriasis versicolor.