A prospective, randomized, open label, comparative study of efficacy & tolerability of oral itraconazole versus combination therapy with oral itraconazole & oral terbinafine in treatment of dermatophytosis

Superficial dermatophytosis is a common dermatosis in clinical practice. They affect skin, hair, nails and are called ‘tinea’ based on the area of involvement. e.g. Tinea pedis/foot, Tinea cruris/groin, Tinea corporis or ringworm in the body, Tinea faciei/Face, Tinea capitis/Scalp

They are generally responsive to topical antifungal agents such as Miconazole, Terbinafine and Butenafine cream, but oral antifungals are indicated for extensive infections, immunocompromised patients and failed topical treatment with Itraconazole, Terbinafine, Griseofulvin, Fluconazole.

The use of Ketoconazole has been limited due to risk of hepatotoxicity. Griseofulvin rapidly clears from the stratum corneum, so it carries the risk of relapse  Fluconazole and Terbinafine are effective but can be used short term or even pulse regimes for treating various superficial fungal infections.

Itraconazole has shown good results in treatment of dermatophytosis at doses of 100mg once a day for 2 weeks and with 200 mg once a day for 1 week. Because of frequent relapses at short intervals, physicians prefer using it in doses of 100mg BID/ 200 mg once a day for prolonged periods.

Terbinafine was considered to be first line drug (250mg OD for 2 weeks) for treatment of Tinea infections. However recently reports of terbinafine resistance with therapeutic failures and relapses have come up. Terbinafine was reported to be efficacious and safe in dermatophytosis with fewer therapeutic failure rates at doses of 500 mg/day.

Over the years, the morphology, course and treatment of Tinea in India has undergone some significant changes. Sufficient data about effectiveness of Oral antifungals is lacking.Although comparative studies have been done among individual drugs, there are limited studies available in India to compare the safety and efficacy of monotherapy with combination therapy of study drugs.

Objectives of the study:

To compare the efficacy & tolerability of monotherapy using oral itraconazole with combination therapy of oral itraconazole & oral terbinafine in treatment of dermatophytosis(tinea corporis ,tinea cruris ,tinea faciei) .

Materials and Methods-

Group A - Oral itraconazole 100 mg BID for 3 weeks

Group B - Oral itraconazole 100 mg BID & oral terbinafine 250 mg OD for 3 weeks

Follow up visits- Done at 3 weeks, 6 weeks and 9 weeks.

•       At each visit, following clinical parameters will be assessed using a 4-point scale

•       Itching

•       Erythema

•       Scaling

•       0 = none; 1 = mild; 2 = moderate; 3 = severe

•       Clinical cure = erythema & scaling grade 0 & itching grade 0 or 1

•       Mycological cure = Negative KOH smear

•       At the end of 3 weeks, subjects who show relapse or partial clinical recovery will be administered with oral Itraconazole 100 mg BID for additional 3 weeks as rescue medication.

•       Tolerability parameters: Whether subjects experience any side effects like GI disturbances, headache, rashes, allergic symptoms