A multicenter, randomized, open-label, controlled study comparing the efficacy, safety and cost-effectiveness of a sequential therapy with RV4104A ointment, ciclopiroxolamine cream and ciclopirox film-forming solution with amorolfine nail lacquer alone in dermatophytic onychomycosis.

BACKGROUND: The efficacy of topical antifungals is controversial. OBJECTIVE: To compare the efficacy and safety of a sequential(SEQ) treatment with chemical nail avulsion and topical antifungals to amorolfine nail lacquer in dermatophytic onychomycosis. METHODS: This was a randomized,parallel-group, controlled study comparing a 36-week SEQ treatment with chemical nail avulsion with RV4104A ointment(class I medical device containing 40% urea) followed by ciclopirox cream for 8 weeks and ciclopirox nail lacquer for 25 weeks (SEQ group) to amorolfine nail lacquer for 36 weeks (AMO group). Patients had to have a big toenail onychomycosis,sparing the matrix. The primary efficacy criterion was complete cure at week 48. A cost-effectiveness analysis was performed. RESULTS: A total of 142 patients were randomized. The complete cure rate at week 48 was significantly higher in the SEQ group than in the AMO group (36.6 vs. 12.7%, p = 0.001). Clinical cure at week 48 was observed in 53.5% of patients in the SEQ group versus 17% in the AMO group (p < 0.01). The cost of cure per patient was 50% lower with SEQ treatment (EUR 33) compared with amorolfine(EUR 76). CONCLUSION: A treatment of onychomycosis comprising chemical avulsion of the pathological nail, ciclopirox cream and nail lacquer is significantly more effective than amorolfine nail lacquer.

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.

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 evaluators and by the investigators. Further studies are needed to assess the impact of preliminary chemical nail avulsion on the efficacy of topical treatment of onychomycosis as assessed by complete cure at 1 year.

Development and validation of nail psoriasis quality of life scale (NPQ10).

BACKGROUND: The chronic and treatment-resistant nature of nail psoriasis affects patients' lives not only physically but also psychologically. Although there are scoring systems available for disease severity, there is as yet no scale to evaluate the impact of this condition upon the patients' quality of life. OBJECTIVES: This study aims to develop and validate a quality of life scale specifically for nail psoriasis. METHODS: A questionnaire was developed during a study conducted in France between 2004 and 2005. With the cooperation of l'Association Pour la Lutte Contre le Psoriasis, the questionnaire was sent to a random sample of 4000 of its 17,000 members. RESULTS: The response rate was 33%. Of the 1309 questionnaires returned, 795 showed the presence of nail psoriasis and these were eligible. The scale score is obtained by adding together the responses to the 10 questionnaire items and the result is expressed as a percentage. The value of the score obtained is proportional to the functional difficulty experienced. The determination of Cronbach's a coefficient and a Principal Component Factor Analysis show, respectively, very good internal consistency and the unidimensional nature of the scale. Test-retest results on 15 patients showed good reproducibility. Results were validated with reference to the Dermatology Life Quality Index. In this study, the NPQ10 score is significantly influenced by gender (women have a higher score) and by the duration of psoriasis (recent onset implies greater functional difficulty). Finally, the score is much higher when the nail psoriasis affects both the hands and the feet. CONCLUSION: This study confirms a change in the quality of life of patients who have nail psoriasis. The NPQ10 scale, specific to this condition, is simple to use and has the attributes needed in a quality of life scale. The scale must now be tested in longitudinal studies (such as clinical trials) to confirm its ability to measure a change in status.

[Management of presumed onychomycosis in private practice]. / Prise en charge des onychopathies présumées d'origine mycosique en dermatologie libérale.

BACKGROUND: The aim of this cross-sectional epidemiological survey was to describe the demographic and clinical characteristics of patients consulting for presumed onychomycosis and methods of treatment used by dermatologists in private practice. PATIENTS AND METHODS: The study was conducted among 209 dermatologists in private practice, and involved 2 041 patients with dermatomycosis, from among whom we isolated a total of 531 subjects with onychomycosis. RESULTS: The most commonly affected site was the foot (92.3%), particularly the big toe (93.9%). Matrix involvement was seen in 46.9% of cases. The clinically suspected diagnosis was confirmed by mycological examination in just under half of these patients. The predominance of trichophyton species was confirmed in 64.4% of cases, with Trichophyton rubrum being the main agent (53.2%) followed by Trichophyton mentagrophytes (10.1%). Results were negative in 25.6% of cases. In most instances, treatment was initiated before the results for samples analysis were received. Oral treatment, either with or without topical therapy, was initiated in 85.3% of cases with matrix involvement and in 34% of cases without matrix involvement. DISCUSSION: This survey reveals a wide disparity in diagnostic criteria for onychomycosis as well as treatment methods among dermatologists in private practice. Mycological samples, which alone can confirm the fungal origin of onychopathy, were taken in less than half of all the cases studied. The most commonly prescribed oral treatment was terbinafine. This was frequently instituted in the absence of any matrix involvement and without confirmation of the diagnosis.

[Leg ulcers and cancer. 6 case reports]. / Ulcères de jambe et cancer. A propos de 6 observations.

OBJECTIVE: It is estimated that 1 leg ulcer out of 300 is a carcinoma. In the literature ulceration of skin cancer is distinguished from chronic leg ulcers although this later category remains a subject of debate. We examined the clinical features of suspected malignant leg ulcers and discuss the notion of secondary malignant transformation of leg ulcers. PATIENTS AND METHODS: This study included patients attending the Vascular Clinic at the Saint-Joseph Hospital in Paris between 1991 and 1999 who were referred for leg ulcers and whose final diagnosis was cancerous ulceration. RESULTS: There were six patients, mean age 77 years who had squamous cell carcinomas (4 cases) and basocellular carcinomas (2 cases). We observed two distinct situations: leg carcinomas that ulcerated from onset (2 cases) and malignant transformation of a cicatrix, known as Marjolin's ulcer (4 cases). There were no cases of malignant transformation of chronic leg ulcers in this series. The clinical elements suggestive of a cancerous leg ulcer were the absence of a vascular etiology, the red, budding aspect of the ulcer with hard borders, and its development on a cicatrix. CONCLUSION: Malignant transformation of a vascular leg ulcer was not observed in our series, but has been reported in the literature although a critical analysis of reported data is only significant for squamous cell carcinoma. The frequency is probably overestimated. Our series enabled us to identify the clinical circumstances leading to an early diagnosis of carcinoma of the lower limbs. There are three essential criteria: analysis of the vascular status of the patient, the clinical characteristics of the leg ulcer, and its development on a cicatrix.

Dermatophytic granuloma caused by Microsporum canis in a heart-lung recipient.

We present a case of dermatophytic granuloma caused by Microsporum canis in a heart-lung recipient. This 66-year-old man was seen for erythematous pustules and papules on the forearm. The diagnosis was suspected after histological examination showing an inflammatory infiltrate in the upper dermis with giant cells containing intracytoplasmic fungal elements. Cultures of the skin biopsy confirmed the diagnosis identifying M. canis. Our case emphasizes the possibility of deep dermatophytic infections in immunocompromised patients. There are only 4 additional reports of M. canis infection responsible for invasion of the dermis in such patients. The follicle involvement probably explains these dermal lesions due to the progression of the dermatophyte from the hair follicle to the dermis. In our observation topical antifungal therapy alone was unsuccessful and fluconazole seems to be the treatment of choice for these M. canis invasive dermal cutaneous infections.