Modified whitfield ointment with oral griseofulvin as a treatment for difficult-to-treat dermatophytosis: a randomized, double-blind, placebo-controlled study

Abstract

Difficult-to-treat dermatophytosis is an emerging public health concern in Sri Lanka because the number of patients who do not respond to standard antifungal treatment is increasing. Safe and cost-effective treatment is needed for these patients. The objective of this study was to assess the effectiveness and safety of modified Whitfield ointment (MWO) applied twice daily with oral griseofulvin 500 mg daily for 8 weeks in patients with difficult-to-treat dermatophytosis. A randomized, double-blind, within-patient- placebo-controlled trial study was conducted on patients with clinically diagnosed difficult-to-treat dermatophytosis without contraindications for trial medications. Lesions in each patient (including lesions in the flexural areas) were randomized to receive either MWO (5% benzoic acid and 5% salicylic acid) or emulsifying ointment (EO) as a placebo. Oral griseofulvin 500 mg daily was given to all patients. The outcome measures were assessed every two weeks up to a maximum of 8 weeks. The calculated sample size was 65. An interim analysis was done after 30 patients had completed the study. At two weeks, there was a statistically significant improvement in the scores of clinical assessment of disease severity and the patient‘s perception in the MWO arm. There was a 7.59% reduction in the surface area of lesions in the MWO arm and a 5.83% increase in the surface area of lesions in the EO arm at two weeks and the difference was not statistically significant. There were no adverse events and application of the MWO to flexural areas did not cause any discomfort. A combination of MWO with griseofulvin is an effective, safe, and affordable option for treating difficult-to-treat dermatophytosis in Sri Lanka.