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Combination of oral terbinafine and topical ciclopirox compared to oral terbinafine for the treatment of onychomycosis.
Volume 16, Number 5-6 / 01Dec2005
Background: Treatment of onychomycosis has recently been enhanced by the introduction of combination therapies. Objective: To evaluate the efficacy of a combination therapy of ciclopirox nail lacquer and oral terbinafine compared to oral terbinafine monotherapy for the treatment of onychomycosis caused by dermatophytes. Patients and methods: Eighty patients with onychomycosis were randomly assigned to receive either oral terbinafine 250 mg/day for 16 weeks or a combination of oral terbinafine 250 mg/day for 16 weeks and topical ciclopirox nail lacquer once daily for 9 months. Both groups were followed up for 9 months from start of treatment. Results: After 9 months of treatment, the mycological cure rates were 22/34 (64.7%) for the terbinafine-only group and 30/34 (88.2%) for the combination therapy group (p<0.05). No significant difference was noted in the complete cure rate. Conclusion: Combination therapy of oral terbinafine and ciclopirox nail lacquer is a safe and more effective treatment for onychomycosis than terbinafine alone, especially in younger patients and in shorter-duration onychomycosis.
Last edited by Admin2 : 19th January 2006 at 05:42 PM.
[b]Combination of oral terbinafine and topical ciclopirox compared to oral terbinafine for the treatment of onychomycosis.
Conclusion: Combination therapy of oral terbinafine and ciclopirox nail lacquer is a safe and more effective treatment for onychomycosis than terbinafine alone, especially in younger patients and in shorter-duration onychomycosis.
I am familiar with terbinafine as a treatment for onychomycosis, but I have not come across ciclopirox - is there a generic / brand name for this nail lacquer? Is it the same as the old Loceryl nail lacquer? And do you know how expensive is it?
An oral(terbenafine) and a topical can work very well in concert.The problem:
1.People that can benefit from the oral meds are VERY reluctant to take it
2.Those who do ask for it will often not be candidates for it(I had a patient with Hep C ask me for lamisil....I declined.On the other hand 2 friends of mine who really have no medical issues looked at me ready to shoot daggers when I suggested that lamisil oral would help their situation.)
Safety and efficacy of oral terbinafine in the treatment of onychomycosis: analysis of the elderly subgroup in Improving Results in ONychomycosis-Concomitant Lamisil and Debridement (IRON-CLAD), an open-label, randomized trial. Am J Geriatr Pharmacother. 2006 Mar;4(1):1-13
OBJECTIVES: The primary objective of this subanalysis was to examine the safety, tolerability, and efficacy of terbinafine in the treatment of toenail onychomycosis in the patients aged > or = 65 years in the Improving Results in Onychomycosis Concomitant Lamisil And Debridement (IRON-CLAD) trial. (Lamisil and IRON-CLAD are trademarks of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.) The secondary objective was to determine if toenail debridement would provide additional efficacy benefits in this subgroup. METHODS: The IRON-CLAD trial was an open-label, randomized, multicenter study of adults who underwent 4 weeks of screening and received terbinafine 250 mg/d for 12 weeks with or without aggressive toenail debridement (at baseline and weeks 6, 12, and 24). Clinic visits occurred at weeks 6, 12, 24, and 48. Safety and tolerability were assessed by adverse event (AE) rates based on changes in laboratory values, patient-volunteered information, answers to investigator questions, and physical examinations. Efficacy was evaluated by mycologic cure (negative microscopy of potassium hydroxide samples and negative culture), clinical cure (> or = 87.5% nail clearing), and complete cure (mycologic cure and complete toenail clearing) at week 48. The present subanalysis of IRON-CLAD results assessed participants aged > or = 65 years (older subgroup). RESULTS: A total of 504 patients were randomized, of whom 75 were aged > or = 65 years. In the older subgroup, the mean (SD) age was 68.9 (3.04), 86.7% (65/75) were white, and 66.7% (50/75) were male. Incidence of AEs reported during the treatment period or within 30 days after treatment discontinuation (treatment-emergent AEs [TEAEs]) was 28.0% in the older subgroup and 23.0% in the overall study population. Most TEAEs were mild (73.7%) to moderate (23.7%) in severity, and most (86.8%) were not suspected by the investigators to be related to study treatment. The most frequently occurring TEAEs in the older subgroup were nausea (4.0%), sinusitis (4.0%) arthralgia (2.7%), and hypercholesterolemia (2.7%). The proportion of participants who withdrew from the trial due to TEAEs was 4.0% (3/75) in the older group and 2.8% (14/504) in the overall population. Only 3 of 11 discontinuations in the older subgroup were due to a TEAE suspected by the investigator to be related to study treatment. Sixty-four percent of the older subgroup took antihypertensive medications, 25% took antidiabetics, and 47% took antilipemic medications. There were no clinical signs of drug interactions in the older subgroup. Clinical efficacy outcomes in the older subgroup were generally good and appeared to be comparable with those in the younger subgroup. At week 48, mycologic cure had occurred in 64.0% (95% CI, 53.1%-74.9%) of the older subgroup, clinical cure in 41.3% (95% CI, 30.2%-52.5%), and complete cure in 28.0% (95% CI, 17.8%-38.2%). Debridement did not appear to affect mycologic outcomes or clinical effectiveness, but rates of clinical and complete cure appeared to be higher among older patients who underwent adjuvant debridement. CONCLUSIONS: The results of this subanalysis suggest that terbinafine was well tolerated and efficacious in these patients aged > or = 65 years with moderate to severe toenail onychomycosis, many of whom were taking antihypertensives, antidiabetics, or lipid-lowering agents concomitantly. There were no reported clinical signs of drug interactions.
An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis.
Jaiswal A, Sharma RP, Garg AP. Indian J Dermatol Venereol Leprol. 2007 Nov-Dec;73(6):393-6.
BACKGROUND: Onychomycosis is a fungal infection of nails caused by dermatophytes, yeasts and molds.
AIMS: To study the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in onychomycosis.
METHODS: A clinical comparative study was undertaken on 96 Patients of onychomycosis during the period between August 2005 to July 2006. Forty-eight patients were randomly assigned in group A to receive oral terbinafine 250 mg, one tablet twice daily for seven days every month (pulse therapy); 24 patients in group B to receive oral terbinafine pulse therapy plus topical ciclopirox olamine 8% to be applied once daily at night on all affected nails; and 24 patients in group C to receive oral terbinafine pulse therapy plus topical amorolfine hydrochloride 5% to be applied once weekly at night on all the affected nails. The treatment was continued for four months. The patients were evaluated at four weekly intervals till sixteen weeks and then at 24 and 36 weeks.
RESULTS: We observed clinical cure in 71.73, 82.60 and 73.91% patients in groups A, B and C, respectively; Mycological cure rates against dematophytes were 88.9, 88.9 and 85.7 in groups A, B and C, respectively. The yeast mycological cure rates were 66.7, 100 and 50 in groups A, B and C, respectively. In the case of nondermatophytes, the overall response was poor: one out of two cases (50%) responded in group A, while one case each in group B and group C did not respond at all.
CONCLUSION: Terbinafine pulse therapy is effective and safe alternative in treatment of onychomycosis due to dermatophytes; and combination therapy with topical ciclopirox or amorolfine do not show any significant difference in efficacy in comparison to monotherapy with oral terbinafine.