Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Sep 14;158(11):1269-1278.
doi: 10.1001/jamadermatol.2022.3745. Online ahead of print.

Effect of Different Itraconazole Dosing Regimens on Cure Rates, Treatment Duration, Safety, and Relapse Rates in Adult Patients With Tinea Corporis/Cruris: A Randomized Clinical Trial

Ananta Khurana  1 , Aastha Agarwal  1 , Diksha Agrawal  1 , Sanjeet Panesar  2 , Manik Ghadlinge  3 , Kabir Sardana  1 , Khushboo Sethia  1 , Shalini Malhotra  4 , Ankit Chauhan  4 , Nirmala Mehta  4
Affiliations

Effect of Different Itraconazole Dosing Regimens on Cure Rates, Treatment Duration, Safety, and Relapse Rates in Adult Patients With Tinea Corporis/Cruris: A Randomized Clinical Trial

Ananta Khurana et al. JAMA Dermatol. .

Abstract

Importance: With worldwide emergence of recalcitrant and resistant dermatophytosis, itraconazole is increasingly being used as the first-line drug for treatment of tinea corporis/cruris (TCC). Apparent inadequacy with low doses has led to empirical use of higher doses and antifungal combinations.

Objective: To compare cure rates, treatment durations, safety profiles, and relapse rates of itraconazole 100, 200, and 400 mg/d for the treatment of TCC.

Design, setting, and participants: This double-blind randomized clinical trial included adult patients with treatment-naive TCC involving at least 5% body surface area. Patients were recruited from the dermatology outpatient department of a tertiary care hospital in New Delhi, India between March 1, 2020, and August 31, 2021.

Interventions: Patients were randomized to 1 of the 3 treatment groups. Biweekly blinded assessments were performed until cure or treatment failure. Posttreatment follow-up of at least 8 weeks was conducted to detect relapses.

Main outcome and measures: Cure rates, treatment durations, safety profiles, and relapse rates were assessed. Secondary outcomes included comparison of rapidity of clinical response and cost-effectiveness between groups.

Results: Of the 149 patients assessed, the mean (SD) age was 34.3 (12.2) years, 69 patients (46.4%) were women, and 80 patients (53.6%) were men. The difference in cure rate between the 100- and 200-mg groups was statistically nonsignificant (hazard ratio [HR], 1.44; 95% CI, 0.91-2.30; P = .12), while the difference between the 100- and 400-mg groups (HR, 2.87; 95% CI, 1.78-4.62; P < .001) and between the 200- and 400-mg groups (HR, 1.99; 95% CI, 1.28-3.09; P = .002) was statistically significant. Mean (SD) treatment durations were statistically significantly different between the 100- and 400-mg groups (7.7 [4.7] weeks vs 5.2 [2.6] weeks; P = .03) and between the 200- and 400-mg groups (7.2 [3.8] weeks vs 5.2 [2.6] weeks; P = .004), but the difference between the 100- and 200-mg groups was not statistically significant. A total of 55 patients (47.4%) relapsed after treatment. Relapse rates were comparable across groups. No patient discontinued treatment due to adverse effects. Treatment with the 200-mg dose incurred a 63% higher cost and 400 mg a 120% higher cost over 100 mg in achieving cure.

Conclusions and relevance: In this randomized clinical trial, high overall efficacy was observed among the 3 itraconazole doses for treatment of TCC, but with prolonged treatment durations and considerable relapse rates. Treatment with the 200- and 100-mg doses did not differ significantly in efficacy or treatment durations, while 400 mg scored over the other 2 on these outcomes. Considerable additional cost is incurred in achieving cure with the 200- and 400-mg doses.

Trial registration: Clinical Trials Registry of India Identifier: CTRI/2020/03/024326.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram
Figure 2.
Figure 2.. Survival Graphs Depicting Proportion of Patients Achieving Cure Over Time With Respect to Various Clinical and Demographic Factors
See this image and copyright information in PMC

Comment in

  • doi: 10.1001/jamadermatol.2022.3736

References

    1. Khurana A, Sardana K, Chowdhary A. Antifungal resistance in dermatophytes: recent trends and therapeutic implications. Fungal Genet Biol. 2019;132:103255. doi:10.1016/j.fgb.2019.103255 - DOI - PubMed
    1. Rudramurthy SM, Shankarnarayan SA, Dogra S, et al. . Mutation in the squalene epoxidase gene of Trichophyton interdigitale and Trichophyton rubrum associated with allylamine resistance. Antimicrob Agents Chemother. 2018;62(5):e02522-e17. doi:10.1128/AAC.02522-17 - DOI - PMC - PubMed
    1. Singh A, Masih A, Khurana A, et al. . High terbinafine resistance in Trichophyton interdigitale isolates in Delhi, India harbouring mutations in the squalene epoxidase gene. Mycoses. 2018;61(7):477-484. doi:10.1111/myc.12772 - DOI - PubMed
    1. Khurana A, Masih A, Chowdhary A, et al. . Correlation of in vitro susceptibility based on MICs and squalene epoxidase mutations with clinical response to terbinafine in patients with tinea corporis/cruris. Antimicrob Agents Chemother. 2018;62(12):e01038-e18. doi:10.1128/AAC.01038-18 - DOI - PMC - PubMed
    1. Singh A, Masih A, Monroy-Nieto J, et al. . A unique multidrug-resistant clonal Trichophyton population distinct from Trichophyton mentagrophytes/Trichophyton interdigitale complex causing an ongoing alarming dermatophytosis outbreak in India: genomic insights and resistance profile. Fungal Genet Biol. 2019;133:103266. doi:10.1016/j.fgb.2019.103266 - DOI - PubMed