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Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

NCT03471455 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-05-01

No results posted yet for this study

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.

Conditions

  • Tinea

Interventions

DRUG

Isotretinoin

Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin

DRUG

Terbinafine

Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin

DRUG

Itraconazole 200 mg

Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Tarun Narang, MD · PGIMER CHANDIGARH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-01-31
Completion
2019-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471455 on ClinicalTrials.gov