Comparative study of ketoconazole versus selenium sulphide shampoo in pityriasis versicolor

Introduction

Pityriasis versicolor, is a mild, chronic infection of the skin caused by Malassezia yeasts, which involves the stratum corneum and is characterised by discrete or concrescent, scaly discoloured or depigmented areas mainly on the upper trunk.[1]

Most patients require treatment as spontaneous remission is uncommon. Different treatment modalities, both topical and systemic are mentioned in the literature. Although various imidozole derivatives such as ketoconazole fluconazole have been used orally in the treatment of pityriasis versicolor in varying doses and regimes, systemic therapy has generally beer reserved for the management of recalcitrant cases those with extensive involvement or those who hay( not responded to other topical monotherapies Various topical agents have been used with limited success because of objectionable odour, messy and frequent application and for prolonged periods Moreover, treatment with these topical agents is associated with high recurrence rates. Therefore the topical preparation in the form of shampoo is preferred because of ease of application to al affected areas of the body and effectively inhibiting the growth of reserves of Malassezia furfur. Moreover, it does not require a prolonged treatment time.

The aim of the present study was to compare the efficacy and relapse rate of ketoconazole shampoo and selenium sulphide shampoo in patients with pityriasis versicolor.

Materials and Methods

Forty patients with pityriasis versicolor were taken for the study. After a detailed history and clinical examination, the diagnosis was confirmed by KOH and Wood′s lamp examination. Patients who had received any systemic or topical antimycotic therapy within a month of the start of the study or had associated dermatophyte infections or any serious concomitant illness were excluded from the study.

Twenty patients were distributed randomly to each group and treated either with 2% ketoconazole shampoo (Group-I) or 2.5% selenium sulphide shampoo (Group-2), applied for five minutes once a week for three weeks. Patients were followed up at monthly intervals for three months from the start of the study. Clinical assessment in terms of prurifus, scaling and erythema was done on a scale of 0-3 (3-severe, 2-moderate, 1-mild, 0-absent). At the end of one month of start of therapy, clinical response was assessed globally with the use of a board scale of healed, mild residual disease, considerable residual disease, unchanged or deteriorated. Patients with assessment in the top two categories, that is, healed and mild residual disease, were considered as responders and the same patients were considered as cured if they had negative KOH smear.[2] Adverse effects, if any, were recorded.

Results

Demographic characteristics of the two groups were similar. Group-1 and Group-2 hoc an average age of 22.85 and 21.2 years respectively. Clinical assessment showed no significant difference in erythema, pruritus and scaling between the two groups before and after the treatment. There was 100% clinical response in Group-1 and 90% clinical response in Group-2. On global assessment, 80% in Group-1 and 65% in Group-2 were considered as healed; 20% in Group-1 and 25% in Group-2 had mild residual disease and 10% in Group-2 had considerable residual. In Group-1, 95% were assessed as cured (clinically and mycologically clear) and 85% in Group-2 [Table - 1]. Fischer′s exact test showed no significant difference in the cure rates between the two groups on global assessment.

Relapse was noted in one (5.26%) patient of ketoconazole group and 2(11.6%) patients of selenium shampoo group during the follow-up period of 3 months. Haemotological and biochemical parameters including liver function tests were within normal limits before and after the treatment. None of the patients, in this study, complained of any side effects that could be attributed to the treatment.

Discussion

In the present study, mycological and clinical cure rate were 95% in ketoconazole group and 85% in selenium sulphide group.

David and Henry[3] reported 74% and 79% of patients as healed, in a study, at day 31 with 1-day and regimen of 2% ketoconazole shampoo, applied locallyforfive minutes on dampened skin. In the present study, in Group-1 of 2% ketoconazole shampoo for five minutes, once weekly for three consecutive weeks, the result was 80% as healed which is comparable to the study by David and Henry.

After one month of therapy, Hersle[4] reported a clinical response rate of 96.8% with a single overnight application of 2.5% selenium sulphide suspension which is comparable to our result of 90% in Group-2 of topical application of 2.5% selenium sulphide shampoo for five minutes, once weekly for three consecutive weeks. Levan[5] used 2.5% selenium sulphide suspension topically on whole body for 5 minutes for three consecutive days and reported a cure rate of 78.3% while Jorge and Victor[6] reported a cure rate of 86.7% using 2.5% selenium sulphide suspension topically on whole body for 5 minutes for three consecutive days and reported a cure rate 78.3% while Jorge and Victor6 reported a cure rate 86.7% using 2.E selenium sulphide lotion for 10 minutes daily for seven consecutive days. Results of both these studies are comparable with the cure rate of 85% of the present study.

The results of the present study suggest tha the efficacy and safety of 2% ketoconazole shampoo are almost similar to that of 2.5% selenium shampoo in the treatment of pityriasis versicolor.