Isotretinoin In Preventing Recurrences In Chronic Recurrent Dermatophytosis

NCT03471455 | Unknown Phase 2

• 1 other identifier: INT/IEC/2017/850
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinea

Outcome Measures

Primary Outcomes (1)

• frequency of recurrences

  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)

  6 months

Study Arms (4)

Terbinafine alone

ACTIVE COMPARATOR

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

Terbinafine plus isotretinoin

ACTIVE COMPARATOR

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; Drug: Terbinafine

Itraconazole only

ACTIVE COMPARATOR

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

Itraconazole plus isotretinoin

ACTIVE COMPARATOR

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; Drug: Itraconazole 200 mg

Interventions

Isotretinoin DRUG

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

Itraconazole plus isotretinoin; Terbinafine plus isotretinoin

Terbinafine DRUG

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

Terbinafine alone; Terbinafine plus isotretinoin

Itraconazole 200 mg DRUG

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

Itraconazole only; Itraconazole plus isotretinoin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Related Publications (1)

• Ardeshna KP, Rohatgi S, Jerajani HR. Successful treatment of recurrent dermatophytosis with isotretinoin and itraconazole. Indian J Dermatol Venereol Leprol. 2016 Sep-Oct;82(5):579-82. doi: 10.4103/0378-6323.183632. No abstract available.

  PMID: 27297276 RESULT

MeSH Terms

Conditions

Tinea

Interventions

Isotretinoin; Terbinafine; Itraconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Tarun Narang, MD

  PGIMER CHANDIGARH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarun Narang, MD

CONTACT

9316063166; narangtarun@yahoo.co.in

RAJSMITA BHATTACHARJEE, MD

CONTACT

9855476633; rajsmita.bee@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 20, 2018
• Study Start: April 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 1, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share