Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a prospective, double blinded, randomized, pilot study to assess the effectiveness of oral low dose isotretinoin in combination with oral terbinafine and itraconazole in preventing recurrences in chronic recurrent dermatophytosis. The recruited patients will be randomized into four treatment arms; oral terbinafine alone and oral itraconazole alone versus oral isotretinoin in combination with each of these two antifungal agents. Randomization will be done using computer generated random number table. The patients in first treatment arm will receive 250 mg of oral terbinafine for 4 weeks, the patients in second treatment arm will receive oral itraconazole 200 mg twice a day for the same duration, while the patients in the third arm will receive oral terbinafine 250 mg once a day for 4 weeks with oral isotretinoin 20 mg once daily and patients in the fourth arm will receive oral itraconazole 200 mg twice a day for 4 weeks with oral isotretinoin 20 mg once daily. In the third and fourth arms, oral terbinafine and oral itraconazole respectively will be stopped after 4 weeks while oral isotretinoin will be continued for 6 months with monthly monitoring of liver function tests and fasting lipid profile.The patients will be followed at monthly intervals for recurrence and treated appropriately.

The primary objective is to evaluate the effectiveness of low dose isotretinoin (20 mg/day) in preventing recurrences in chronic recurrent dermatophytosis by comparing the frequencies of recurrence in patients who are on low dose isotretinoin during the follow up versus those who are not comparing the disease free interval between the four randomized groups at monthly follow up for a total duration of 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Hydroxyitraconazole; Isotretinoin; Itraconazole; Terbinafine

Criteria

Inclusion Criteria:

• All patients with chronic recurrent dermatophytosis of more than 6 months duration who have been adequately treated for every episode still developing recurrences within one month of stopping oral antifungal drugs.

Exclusion Criteria:

• Patients with contraindications to receiving oral terbinafine, itraconazole or isotretinoin like those suffering from congestive cardiac failure, cardiac arrhythmias, liver or kidney function impairment or are on drugs whose plasma concentrations are likely to be increased by the concurrent administration of oral itraconazole.

• Pregnancy and lactation.

• Patients on immunosuppressive drugs.

• Immunocompromised patients (HIV positive/renal transplant etc).