Efficacy and safety of 250 mg versus 500 mg oral terbinafine in the treatment of tinea corporis and cruris: A randomised, assessor-blinded comparative study.

Background Though higher doses of terbinafine are often prescribed to treat dermatophyte infections, it is unknown if such doses are more effective than the conventional dose because comparative data are unavailable. Aim To compare the efficacy and safety of a once-daily dose of oral terbinafine 250 mg with 500 mg along with topical clotrimazole in the treatment of tinea infections. Methods A randomised, assessor-blinded, comparative study was carried out. Each group of subjects were administered either 250 mg or 500 mg oral terbinafine once daily for four weeks, along with topical clotrimazole. Clinical improvement was assessed after two weeks and again after four weeks from treatment initiation. Result A total of 60 patients with tinea corporis and cruris were randomised into two groups receiving either 250 mg (group A) or 500 mg (group B) oral terbinafine, along with clotrimazole cream in both groups. Baseline clinical parameters such as lesional activity (papules, vesicles and pustules), degree of erythema, scaling and severity of itching were comparable between both treatment arms. At the first and second follow-ups, no significant differences were found in the clinical parameters between the two groups. At the end of two weeks 13.8% of group A and 14.3% of group B and after 4 weeks 25.9% of group A and 33.3% of group B participants became KOH negative (P = 1.00 and 0.76, respectively). No significant difference in culture negativity was reported at the end of therapy (four weeks) between the two treatment arms (P = 0.78). Overall cure rates were 20% and 33.3% in the two treatment arms respectively at the end of the study (P = 0.82). Conclusion Oral terbinafine 250 mg daily yielded a poor cure rate in tinea cruris and corporis after 4 weeks of treatment and an increased dose of 500 mg did not have any additional benefit.

Fractional CO2 laser with topical 1% terbinafine cream versus oral itraconazole in the management of onychomycosis: A randomized controlled trial.

Background Onychomycosis accounts for 20-40% of all nail disorders. It is difficult to cure with resistance to anti-fungal drugs, their side effects and drug interactions limiting treatment options. Itraconazole is a widely accepted oral medication used for onychomycosis while fractional CO2 laser along with a topical anti-fungal has shown promising results for nail plate clearance in onychomycosis. Aim To compare the efficacy of fractional CO2 laser with 1% terbinafine cream versus itraconazole in the management of onychomycosis. Methods A prospective, randomised, single-centre, two-arm, parallel-group interventional study was conducted at Command Hospital Air Force, Bangalore. Onychomycosis cases confirmed by KOH mount/culture-positive were included. Patients were randomly divided into two groups. Group A received 4 sessions of fractional CO2 laser every fourth week with twice-daily application of 1% terbinafine cream; Group B received one-week pulse therapy with capsule itraconazole once every four-week for three pulses. The response was assessed by Onychomycosis Severity Index, a validated onychomycosis assessment scale, at baseline and at six months. Results Group A had 50 patients with a total of 98 nails. Clinical improvement was seen in 83/98 (84.7%) nails. The average reduction in Onychomycosis Severity Index was 8.65 (P < 0.05). Group B had 50 patients with a total of 136 nails. Clinical improvement was seen in 104/136 (76.5%) nails. The average reduction in Onychomycosis Severity Index was 7.37 (P < 0.05). Both groups showed statistically significant improvement measured by 'Reduction in Onychomycosis Severity Index' at six months; however, there was no significant difference between the two arms. Limitations The main limitations of the study are the small sample size and lack of long-term follow-up to assess recurrence of infection. Conclusion Fractional CO2 laser with 1% terbinafine cream is an effective and safe method for inducing nail clearance in onychomycosis and has efficacy similar to itraconazole pulse therapy.

Molecular epidemiology and clinical-laboratory aspects of chromoblastomycosis in Mato Grosso, Brazil.

INTRODUCTION: Chromoblastomycosis is a disease caused by melanized fungi, primarily belonging to the genera Fonsecaea and Cladophialophora, mainly affecting individuals who are occupationally exposed to soil and plant products. This research aimed to determine the clinical, epidemiological and laboratory characteristics of chromoblastomycosis in the state of Mato Grosso, Brazil. MATERIALS AND METHODS: Patients diagnosed with chromoblastomycosis treated at the Júlio Müller University Hospital, Cuiabá, Brazil, from January 2015 to December 2020, whose isolates were preserved in the Research Laboratory of the Faculty of Medicine of the Federal University of Mato Grosso. Isolates were identified by partly sequencing the Internal Transcribed Spacer (ITS) and ß-tubulin (BT2) loci. AFLP fingerprinting was used to explore the genetic diversity. Susceptibility to itraconazole, voriconazole, 5-fluorocytosine, terbinafine and amphotericin B was determined by the broth microdilution technique. RESULTS: Ten patients were included, nine were male (mean age = 64.1 years). Mean disease duration was 8.6 years. Lesions were mainly observed in the lower limbs. Predominant clinical forms were verrucous and scarring. Systemic arterial hypertension and type II diabetes mellitus were the predominant comorbidities. Leprosy was the main concomitant infectious disease. Fonsecaea pedrosoi was the unique aetiological agent identified with moderate genetic diversity (H = 0.3934-0.4527; PIC = 0.3160-0.3502). Antifungal agents with the highest activity were terbinafine, voriconazole and itraconazole. CONCLUSION: Chromoblastomycosis is affecting the poor population in rural and urban areas, mainly related to agricultural activities, with F. pedrosoi being the dominant aetiologic agent. All isolates had low MICs for itraconazole, voriconazole and terbinafine, confirming their importance as therapeutic alternatives for chromoblastomycosis.

End of the road for terbinafine? Results of a pragmatic prospective cohort study of 500 patients.

BACKGROUND: There is a general impression among dermatologists in India that terbinafine has been losing its effectiveness in dermatophytoses over the past few years, but there are no recent data to support this. AIMS: To determine the effectiveness of terbinafine in tinea corporis, tinea cruris and tinea faciei with a pragmatic prospective cohort study. METHODS: A sample size of 361 patients was calculated taking a 5% margin of error and a 95% confidence level. Five hundred patients with tinea corporis, tinea cruris and tinea faciei confirmed by potassium hydroxide microscopy received oral terbinafine (5mg/kg/day) and topical terbinafine 1% applied twice daily for 4 weeks. Patients were evaluated at 2 and 4 weeks. Cure was defined as total clearance of lesions and negative microscopy. RESULTS: Patients who came for follow-up at 2 and 4 weeks numbered 357 and 362 respectively. Ten patients were cured at 2 weeks (cure rate 2%, 95% confidence interval 1.0-3.7%, intention-to-treat analysis) and 153 patients were cured at 4 weeks (cure rate 30.6%, 95% confidence interval 26.7-34.8%). LIMITATIONS: Culture and antifungal susceptibility testing were not performed since this was a pragmatic study. There was also no follow up after completion of treatment to check for relapses, but the poor response makes this less relevant. CONCLUSION: The effectiveness of terbinafine in dermatophytosis was abysmal in this study.