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Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis (ISORD)

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ClinicalTrials.gov Identifier: NCT03471455
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Tarun Narang, Postgraduate Institute of Medical Education and Research

Brief 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.


Condition or disease Intervention/treatment Phase
Tinea Drug: Isotretinoin Drug: Terbinafine Drug: Itraconazole 200 mg Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess The Therapeutic Effectiveness Of Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
Active Comparator: Terbinafine alone
Patients of recurrent dermatophytosis (recurrent episodes for more than 6 months) will receive oral terbinafine 250 mg once a day for 4 weeks.
Drug: Terbinafine
Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin

Active Comparator: Terbinafine plus isotretinoin
Patients of recurrent dermatophytosis (recurrent episodes for more than 6 months) will receive oral terbinafine 250 mg once a day for 4 weeks and oral isotretinoin 20 mg/ day for 6 months.
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

Active Comparator: Itraconazole only
Patients of recurrent dermatophytosis (recurrent episodes for more than 6 months) will receive oral itraconazole 200 mg twice a day for 4 weeks.
Drug: Itraconazole 200 mg
Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin

Active Comparator: Itraconazole plus isotretinoin
Patients of recurrent dermatophytosis (recurrent episodes for more than 6 months) will receive oral itraconazole 200 mg twice a day for 4 weeks and oral isotretinoin 20 mg/ day for 6 months.
Drug: Isotretinoin
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




Primary Outcome Measures :
  1. frequency of recurrences [ Time Frame: 6 months ]
    The total number of patients who recur in the 4 different groups (comparing the paticipants who are on low dose isotretinoin during the follow up versus those who are not)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471455


Contacts
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Contact: Tarun Narang, MD 9316063166 narangtarun@yahoo.co.in
Contact: RAJSMITA BHATTACHARJEE, MD 9855476633 rajsmita.bee@gmail.com

Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Tarun Narang, MD PGIMER CHANDIGARH

Publications of Results:
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Responsible Party: Dr. Tarun Narang, ASSISTANT PROFESSOR, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03471455     History of Changes
Other Study ID Numbers: INT/IEC/2017/850
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Terbinafine
Recurrence
Tinea
Disease Attributes
Pathologic Processes
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Itraconazole
Hydroxyitraconazole
Isotretinoin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Dermatologic Agents