Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis (ISORD)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03471455 |
Recruitment Status : Unknown
Verified March 2018 by Dr. Tarun Narang, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : May 1, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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 |
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
Contact: Tarun Narang, MD | 9316063166 | narangtarun@yahoo.co.in | |
Contact: RAJSMITA BHATTACHARJEE, MD | 9855476633 | rajsmita.bee@gmail.com |
Principal Investigator: | Tarun Narang, MD | PGIMER CHANDIGARH |
Responsible Party: | Dr. Tarun Narang, ASSISTANT PROFESSOR, Postgraduate Institute of Medical Education and Research |
ClinicalTrials.gov Identifier: | NCT03471455 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Tinea Recurrence Disease Attributes Pathologic Processes Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases Itraconazole Terbinafine 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 |