Terbinafine Cream Research Articles

A randomized, double-blind, placebo-controlled, pilot study of 1% terbinafine cream applied twice daily and delivered via nail plate microporation for the treatment of subungual toenail onychomycosis

A randomized, double-blind, placebo-controlled, pilot study of 1% terbinafine cream applied twice daily and delivered via nail plate microporation for the treatment of subungual toenail onychomycosis

Combination of pulse therapy with terbinafine tablets and topical terbinafine cream for the treatment of dermatophyte onychomycosis: A pilot study

We performed a pilot study to assess the safety and efficacy of pulse therapy with terbinafine tablets in 66 patients with dermatophyte onychomycosis. One pulse consisted of oral terbinafine tablets (500 mg/day) given for 1 week followed by a 3-week interval. Topical 1% terbinafine cream was applied daily. The number of pulses was determined by the extent of improvement in the affected nails and by the patient's requests, up to a maximum of six pulses. Efficacy was assessed based on both clinical and mycological examinations 1 year after treatment initiation. We observed a complete cure in 51 patients (77.3%), marked improvement in five patients (7.6%), improvement in five patients (7.6%) and slight improvement in one patient (1.5%). Four patients (6.0%) showed no change. In the patients who were completely cured, the average number of pulses used was 3.7 +/- 1.4 pulses and the treatment duration was 3.3 +/- 1.6 months. Nine patients experienced adverse effects, consisting of gastrointestinal disturbance (eight patients) and drug-induced eruption (one patient). There were no abnormal findings in the laboratory tests, including liver function tests. In summary, terbinafine pulse therapy in combination with topical application of terbinafine cream appeared safe and effective in this pilot study.

爪真菌症に対する terbinafine クリーム単純塗布療法の検討

爪真菌症に対する terbinafine クリーム単純塗布療法の検討

Combination therapy consisting of week pulses of oral terbinafine plus topical application of terbinafine cream in the treatment of onychomycosis

BACKGROUND: Terbinafine, based on its pharmacokinetic properties, is a good candidate for pulse therapy. There are, as yet, no current guidelines for a terbinafine 1‐week pulse regimine.OBJECTIVE: To determine the optimal 1‐week pulse dosing regimen for combination therapy of oral terbinafine with complementary 1% terbinafine cream for the treatment of onychomycosis.DESIGN: A total of 69 onychomycosis patients received 250 mg terbinafine, given orally once daily for 7 days as 1‐week pulses, separated by intervals of 2–3 weeks, until the desired improvement was observed. A daily application of 1% terbinafine cream was advised through to the evaluation date at 12 months follow‐up. The treatment regimens were compared based on the number of pulses and the duration of treatment.RESULTS: The 45 patients (65.2%) who achieved complete cure received an average of 7.8±3.5 pulse treatments over 4.8±2.6 months. The optimal terbinafine dosing regimen consisted of alternate 1‐week pulses, with most patients on this regimen (19/20 cases; 95%) achieving total cure.CONCLUSION: Favorable treatment outcome was gained from this terbinafine 1‐week pulse regimen and also better compliance compared with a standard daily regimen.

Coexistent cutaneous Aspergillus and cytomegalovirus infection in a liver transplant recipient

Cutaneous infections are a significant cause of morbidity in solid organ recipients. These infections may be complex with multiple pathogens occurring in the same lesion. We describe the unusual association of cutaneous Aspergillus and cytomegalovirus (CMV) infections in a liver transplant recipient. Cutaneous CMV infection is rare and often indicates severe systemic involvement, whereas Aspergillus is a frequent cause of opportunistic cutaneous fungal infection. Seven weeks after liver transplantation, our patient had hemorrhagic, eroded plaques develop on his arms. The results of routine histology, immunoperoxidase staining for CMV antibody, and fungal culture revealed coexistent cutaneous Aspergillus flavus and CMV infections. The patient was treated with ganciclovir, amphotericin B, and topical terbinafine cream; however, 2 weeks after the development of the cutaneous lesions, the patient died. (J Am Acad Dermatol 2001;44:370-2.)

Effectiveness of treatment of severe tinea pedis with 1% terbinafine cream in members of the Japanese self-defense forces.

A clinical study was conducted to determine the efficacy of terbinafine cream in severe cases of tinea pedis. The subjects were 21 men, members of the Japanese Self-Defense Forces who were judged to have severe symptoms of tinea pedis. The description 'severe' was defined as 'considered to require the concurrent internal administration of antifungals for complete cure', or as meeting criterion 5 or 6 for the severity of tinea pedis. A simple surface application of terbinafine cream was given once daily, the subjects' clinical manifestations, mycological cure rates and safety-related changes were observed, and a final assessment was made in the 12th week. In the final assessment, the improvement rate of the cutaneous symptoms was 95.2%, and the fungal eradication and efficacy rates were 81.0%. As for side-effects, one patient complained of local irritation. These results suggested that terbinafine cream is a beneficial topical antifungal cream for severe tinea pedis.

Long QT Interval in a Young Woman with Severe Weakness

A 19-year-old woman was admitted to the hospital after she called emergency medical services because of severe weakness. The patient had been under psychiatric care for several years for an eating disorder, but she had considered herself to be in good health physically. Her medications included 20 mg of cisapride three times a day, terbinafine cream daily, 20 mg of fluoxetine daily, and calcium and potassium supplements daily.The patient was thin and in no acute distress, except for severe generalized muscular weakness. Her pulse was 60 beats per minute and regular; blood pressure, 95/65 mm Hg; respirations, 16 per minute; and temperature, 36.8°C. Her general and neurologic examinations were unremarkable except for generalized muscular weakness.The ECG recorded in the emergency department is shown.

Open clinical study of the efficacy and safety of terbinafine cream 1% in children with tinea corporis and tinea cruris

Topical application of antifungal agents is considered the treatment of choice for dermatomycoses. Most of the available drugs are fungistatic, requiring long term treatment to prevent relapses. Terbinafine is a synthetic antifungal agent that, because of its fungicidal action, provides high cure rates and low relapse rates after short periods of treatment. Ninety-seven children ages 2 to 15 years with a suspected diagnosis of tinea corporis and/or tinea cruris were enrolled in this open trial. After mycologic assessment to confirm diagnosis (culture and direct microscopy) terbinafine 1% cream was applied once daily during 1 week. Clinical and mycologic assessments were made at the baseline visit and on Days 7, 14 and 21. Efficacy assessment was based on 88 children (9 patients excluded by protocol violation). Therapy was considered effective in 92.0% (81 of 88) of patients (complete clinical and mycologic cure or mycologic cure with minimum signs and symptoms or clinical improvement, > or = 50%). Tolerability was assessed in 97 patients on an intention-to-treat basis. Adverse reactions were itching 3% (3 of 97), itching associated with erythema exacerbation 1% (1 of 97) and contact dermatitis 1% (1 of 97). Terbinafine 1% cream appears to be an effective and well-tolerated treatment for tinea corporis and tinea cruris in children.

Tinea pedis: Clinical Experience and Efficacy of Short Treatment

Tinea pedis is the commonest fungal infection in developed countries. Topical therapy is an accepted and successful method for the management of this condition. This has usually involved the application of an antifungal twice or 3 times a day for 3-4 weeks to achieve a cure rate of > or = 80%. Terbinafine, a new antifungal, has been shown in a number of studies to give equally good results when applied once or twice daily for 1-2 weeks. In one study, a cure rate of 78% was achieved in patients with tinea pedis after a single application of 1% terbinafine cream, demonstrating the high potency of this antifungal. Topical terbinafine has also been compared to clotrimazole for the treatment of tinea pedis. Terbinafine 1% cream applied twice daily for 1 week was significantly superior to a 4-week course of clotrimazole 1% cream for treating this common mycosis. Overall, the high efficacy of topical terbinafine in treating tinea pedis following such-short-duration therapy is undoubtedly due to its fungicidal mode of action.

A double-blind multicentre trial of 1% terbinafine cream (1 wk) vs 1% clotrimazole cream (4 wks) in tinea pedis

A double-blind multicentre trial of 1% terbinafine cream (1 wk) vs 1% clotrimazole cream (4 wks) in tinea pedis

One week treatment with local terbinafine cream (Lamisil) has the same clinical efficacy as four weeks treatment with local miconazol cream (Daktarin)

One week treatment with local terbinafine cream (Lamisil) has the same clinical efficacy as four weeks treatment with local miconazol cream (Daktarin)

Primary cutaneous infection by Aspergillus ustus in a 62-year-old liver transplant recipient

We report the first case of primary cutaneous aspergillosis caused by Aspergillus ustus, a species that seldom infects human beings. The patient, a 62-year-old liver transplant recipient with end-stage hepatitis C-induced cirrhosis, was receiving the experimental immunosuppressive drug FK-506. Trauma to the skin of the right arm from tape and from an arm board holding intravenous and intraarterial catheters in place and to the left leg from an occlusive knee brace may have contributed to this unusual mycosis. The patient's cutaneous aspergillosis responded to a combination of intravenous amphotericin B and topical terbinafine cream. Although the patient died shortly thereafter from hepatic failure, there was no evidence of systemic aspergillosis.

The route of rapid access of drugs to the distal nail plate.

It has recently been shown that antimycotic drugs have unexpectedly rapid access to distal nail, which we have suggested occurs through the site of continuous ventral nail formation along the nail bed. To exclude the alternative possibility of diffusion through the nail plate, we have measured the effect of topical terbinafine cream in onychomycosis. Sustained outward movement of the fungally affected distal segment was seen in only 2 of 10 measured nails, and there was no change in the mean severity of clinical involvement in 53 nails under study. This excludes significant diffusion of drugs through the nail plate, and we conclude that the route of rapid access is indeed through the nail bed.

The route of rapid access of drugs to the distal nail plate.

It has recently been shown that antimycotic drugs have unexpectedly rapid access to distal nail, which we have suggested occurs through the site of continuous ventral nail formation along the nail bed. To exclude the alternative possibility of diffusion through the nail plate, we have measured the effect of topical terbinafine cream in onychomycosis. Sustained outward movement of the fungally affected distal segment was seen in only 2 of 10 measured nails, and there was no change in the mean severity of clinical involvement in 53 nails under study. This excludes significant diffusion of drugs through the nail plate, and we conclude that the route of rapid access is indeed through the nail bed.

Clinical efficacy and tolerability of terbinafine in patients with pityriasis versicolor

The antifungal efficacy and tolerability of 1% terbinafine cream vs. 1% bifonazole cream were assessed in a single blind randomized trial in patients with pityriasis versicolor. Terbinafine, a drug of the allylamines group, a new class of anti-mycotic agents, blocks sterol biosynthesis in the pathogen through inhibition of squalene epoxidase and consequent squalene accumulation, a primarily fungicidal process. Forty pityriasis versicolor patients, (18 M, 22 F; mean age 32.4 years; min. 16, max. 65), used 1% terbinafine cream or 1% bifonazole cream for a maximum of 4 weeks. All patients were followed-up weekly both clinically and mycologically. Clinical cures, defined as negativization of each clinical parameter, were recorded for 20 terbinafine patients (100%) and 19 bifonazole patients (95%), with routine microscopy and Wood's light tests both negative. By the 2nd week of treatment, 2 terbinafine patients were mycologically cured (10%). By the 3rd week, 14 terbinafine patients (70%) and 5 bifonazole patients (25%) were mycologically cured. The present controlled clinical trial consequently demonstrates that terbinafine is rapidly effective and well tolerated for treatment of pityriasis versicolor.

Tinea Corporis Due to Microsporum canis from an Asymptomatic Dog

The patient was a 19-year-old female student who purchased a puppy from a pet shop four weeks earlier. At the time of her first examination, an annular edematous erythema with adherent scales and vesicles surrounding its margin was seen on the left forearm. On direct examination of the vesicles, fungal elements were detected, and Microsporum canis was isolated. The puppy was a Pomeranian and was kept in the house at all times. No clinical lesions were seen on the puppy, and the Wood's lamp test was negative. However, M. canis was isolated from the animal by the hairbrush method. Symptoms disappeared after the patient was treated topically with terbinafine cream for three weeks. Although the dog received no treatment whatsoever, there was no evidence of the disease on the pet. Results of the hairbrush method performed on the pet two and three weeks later were negative, but, at five weeks, it was again positive. Human infection with M. canis from an asymptomatic dog was demonstrated in this case. Attention should be paid to preventing infections from animals without lesions.

Ｔｅｒｂｉｎａｆｉｎｅ１％クリーム剤の表在性皮膚真菌症に対する臨床評価

Ｔｅｒｂｉｎａｆｉｎｅ１％クリーム剤の表在性皮膚真菌症に対する臨床評価

Pharmacokinetics of topically applied terbinafine: results from studies in healthy volunteer subjects and patients with pityriasis versicolor

The percutaneous penetration of the antimycotic terbinafine (Lamisil, SF86–327) has been assessed after topical application in patients with pityriasis versicolor and normal volunteer subjects. Plasma samples were analysed by high-pressure liquid chromatography (HPLC). In 10 patients with pityriasis versicolor plasma levels over a 28–day period did not exceed 24.8 ng/ml. There was no evidence of long-term accumulation in these patients. Similar results were obtained with a group of 8 normal volunteer subjects where the maximum plasma level recorded after application of 1% terbinafine cream over 8 days was 11.4 ng/ml. Significantly higher values were not recorded in normal subjects with reduced barrier function. The two main metabolites of terbinafine, carboxybutyl and demethyl carboxybutyl terbinafine, were also measured by HPLC in the urine of the normal volunteer subjects. There was no evidence of long-term accumulation of the terbinafine or its metabolites in these subjects.

Terbinafin 1% Cream and Ketoconazole 2% Cream in the Treatment of Pityriasis Versicolor: A randomized comparative clinical trial.

Objective: To make a comparison between terbinafine 1% cream and ketoconazole 2% cream in the treatment of pityriasis versicolor. Methods: This randomized single blind study included 110 patients with clinical diagnosis of pityriasis versicolor and positive mycological test for Malassezia furfur. The patients were randomly assigned to two groups. Group 1 used terbinafine cream and group 2 applied ketoconazole cream on the skin lesions for two weeks. Each group consisted of 55 patients. Clinical and mycological examinations were performed at baseline, at the end of the 2nd, 4th and 8th week of starting the treatment regimens. Results: At the end of the 2nd week we achieved cure rates of 72% and 64.3% for group 1 and group 2 respectively. At the end of the 4th week the respective cure rates for group 1 and group 2 were 81.2% and 69%, and at the end of the 8th week 70.8% of the patients in group 1 and 61.9% of the patients in group 2 were cured. Conclusion: The results of this study showed no significant statistical differences between the two groups in regard to cure and recurrence rates. But the numbers of cured patients were higher and recurrent cases were lower in group 1.