Topical Treatment of Onychomycoses with Bifonazole-Urea Ointment

Stettendorf, S.

doi:10.1007/978-3-642-75409-8_11

Cited by 5 publications

(7 citation statements)

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“…In clinical trials, the drug has been successfully administered in patients with onychomycosis, displaying a success rate of 76%. In most patients, the time of ointment application until complete removal of the nail was reported to be less than 2 weeks [3], 'ITiesc data go along well with the findings reported in the present study. However, it would be of interest to correlate the clinical improvement of onychomycosis with ultrastructural observations in future studies.…”

Section: Discussionsupporting

confidence: 91%

“…tion of the azole derivative, bifonazole, in combination with 40% urea as an ointment has been introduced [3]. This combination is thought to combine the well-documented antifungal activity of bifonazole [4,5] with the known keratoplastic effect of urea [6].…”

Section: Introductionmentioning

confidence: 99%

“…This combination is thought to combine the well-documented antifungal activity of bifonazole [4,5] with the known keratoplastic effect of urea [6]. In numerous clinical trials, the efficacy of this ointment has been demonstrated [3]. How …”

Section: Introductionmentioning

confidence: 99%

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Ultrastructural Changes in Onychomycosis during the Treatment with Bifonazole/Urea Ointment

Fritsch

Stettendorf

1992

Dermatology

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In the present study, we investigated the effects of bifonazole/urea ointment, a novel topical drug for the treatment of onychomycosis, on the ultrastructure of normal and fungus-infected human toenails by scanning electron microscopy. Nails were treated with the drug ex vivo and compared to untreated controls. During treatment, the corneocyte layers disintegrated, and the structure markedly loosened. After 5 days of treatment, the morphology of fungal cells, found at the undersurface of infected nails, was changed due to the antifungal drug action. The present data demonstrate that by the use of this drug, the agent effectively penetrates the nail plate and affects the fungal cells.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

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Ultrastructural Changes in Onychomycosis during the Treatment with Bifonazole/Urea Ointment

Fritsch

Stettendorf

1992

Dermatology

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“…40% urea ointment with plastic dressing followed by one-time physician-driven debridement demonstrated its superior efficacy in comparison with bifonazole-urea treatment combined with daily scraping by patients themselves. As clinical experience suggests, topical therapy associated with debridement increases the likelihood of therapeutic success [13,14,15,16,17,18,19]. …”

Section: Discussionmentioning

confidence: 99%

“…Several studies evaluating the efficacy of 40% urea for nail avulsion have been reported [9,10]. The combination of 40% urea and 1% bifonazole associated with patient-driven nail avulsion has been approved for use in some countries for the treatment of toenail onychomycosis [11,12,13,14,15,16,17,18]. A new ointment containing 40% urea (40% urea ointment with plastic dressing Onyster; Pierre Fabre Dermatologie) has been developed to promote physician-driven pathological nail avulsion in onychomycosis.…”

Section: Introductionmentioning

confidence: 99%

Efficacy, Safety and Tolerability of an Optimized Avulsion Technique with Onyster® (40% Urea Ointment with Plastic Dressing) Ointment Compared to Bifonazole-Urea Ointment for Removal of the Clinically Infected Nail in Toenail Onychomycosis: a Randomized Evaluator-Blinded Controlled Study

Lahfa

Livideanu

Baran³

et al. 2013

Dermatology

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Background: Toenail onychomycosis is highly prevalent, with 14-28% of people aged 60 or over suffering from the disease. Use of a topical antifungal alone in toenail onychomycosis is associated with low cure rates. This may be due to limited penetration of the topical antifungal through the diseased nail. The objective of the present study was to compare two treatment modalities to obtain diseased nail chemical avulsion in toenail onychomycosis. Methods: In this European, multicenter, randomized, parallel-group, open-label, active-controlled study, male or female adult patients with distal-lateral or lateral subungual dermatophyte onychomycosis on at least 12.5% of the great toenail were randomized either to a 40% urea ointment with plastic dressing group (n = 53) or to a bifonazole-urea ointment group (n = 52). The ointments were applied daily for a maximum of 3 weeks according to the summary of product characteristics. After assessment of infected nail debridement, topical antifungal treatment with bifonazole cream was applied daily in both groups for 8 weeks. 102 patients were evaluated, i.e. 51 in the 40% urea ointment with plastic dressing group and 51 in the bifonazole-urea group. The primary end point was complete removal of the nail plate at day 21 (D21). Secondary end points were: complete cure and mycological cure evaluated at D105. Ease of use and local tolerability were also assessed. Results: Complete removal of the clinically infected target nail plate area, assessed by blinded evaluators, was significantly higher in the 40% urea ointment with plastic dressing group (61.2%) than in the control group (39.2%), showing the superiority of 40% urea ointment with plastic dressing (p = 0.028). The same results were observed in the per-protocol population (63.0 vs. 36.6%; p = 0.014). Complete removal of the infected area assessed by the investigator at D21 showed a significantly higher success rate in patients treated with 40% urea ointment with plastic dressing (86.3%) as compared to patients treated with bifonazole-urea (60.8%), confirming the superiority of 40% urea ointment with plastic dressing (p = 0.004). At D105, the complete cure of onychomycosis, a criterion combining clinical and mycological assessments, showed a success rate of 27.7% for 40% urea ointment with plastic dressing versus 20.8% for the control group. No statistical difference was observed between the two treatment groups. The number of patients with at least one adverse event was twice as high in the bifonazole-urea group in comparison to the 40% urea ointment with plastic dressing group. Overall assessment of local tolerability by the investigator was considered good/very good in 98.0% of the 40% urea ointment with plastic dressing patients versus 90.4% of the bifonazole-urea patients, at D21, with no significant difference between both groups. Conclusion: This study shows the superiority of 40% urea ointment with plastic dressing to bifonazole-urea ointment for complete removal of the infected target nail assessed by blinded evalua...

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Therapeutic strategies in onychomycosis

Effendy

1995

Journal of the European Academy of Dermatology and Venereology

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Topical Treatment of Onychomycoses with Bifonazole-Urea Ointment

Cited by 5 publications

References 5 publications

Ultrastructural Changes in Onychomycosis during the Treatment with Bifonazole/Urea Ointment

Ultrastructural Changes in Onychomycosis during the Treatment with Bifonazole/Urea Ointment

Efficacy, Safety and Tolerability of an Optimized Avulsion Technique with Onyster® (40% Urea Ointment with Plastic Dressing) Ointment Compared to Bifonazole-Urea Ointment for Removal of the Clinically Infected Nail in Toenail Onychomycosis: a Randomized Evaluator-Blinded Controlled Study

Therapeutic strategies in onychomycosis

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