| 1. |
- Alsterholm, Mikael, 1977, et al.
(författare)
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Frequency of bacteria, Candida and malassezia species in balanoposthitis.
- 2008
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Ingår i: Acta dermato-venereologica. - : Medical Journals Sweden AB. - 0001-5555 .- 1651-2057. ; 88:4, s. 331-6
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Tidskriftsartikel (refereegranskat)abstract
- Balanoposthitis is an inflammatory disorder of the prepuce and glans penis. Microbes involved in balanoposthitis have been investigated, but no single study has covered the growth of both bacteria, Candida and Malassezia. We report here the prevalence of these microbes in 100 patients with balanoposthitis and in 26 control patients. Among patients with balanoposthitis there was a significantly higher frequency of positive cultures than in the control group (59% and 35%, respectively, p<0.05). In the balanoposthitis group Staphylococcus aureus was found in 19%, group B streptococci in 9%, Candida albicans in 18% and Malassezia in 23% of patients. In the control group S. aureus was not found at all, whereas C. albicans was found in 7.7% and Malassezia in 23% of patients. Different microbes did not correspond with distinct clinical manifestations. In summary, we report increased frequency of microbes, specifically S. aureus, in the area of the prepuce and glans penis in balanoposthitis.
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| 2. |
- Baran, R., et al.
(författare)
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A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement
- 2007
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Ingår i: Br J Dermatol. ; 157:1, s. 149-57
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Onychomycosis is common, accounting for up to 50% of all nail disorders. Toenail onychomycosis can cause nail deformity, embarrassment, pain and walking difficulties. Some populations, such as individuals with diabetes, are at higher risk for developing secondary complications such as infections. Treatment takes many months and therapeutic choices can increase clinical effectiveness, lower toxicity and minimize healthcare costs. OBJECTIVES: Based on the results of a previous pilot study, the objective of the present study was to show, in a larger population, the enhanced efficacy of a combination of amorolfine nail lacquer and oral terbinafine in the treatment of onychomycosis with matrix involvement. In addition, a cost-effectiveness analysis was performed. METHODS: In this multicentre, randomized, open-label, parallel group study, patients were randomized to receive either a combination of amorolfine hydrochloride 5% nail lacquer once weekly for 12 months plus terbinafine 250 mg once daily for 3 months (AT group) or terbinafine alone once daily for 3 months (T group). The study duration was 18 months including a 6-month treatment-free phase following the 12-month active treatment phase for the AT group and a 15-month treatment-free phase following the 3-month active treatment phase for the T group. The primary efficacy criterion was overall response, dichotomized into success or failure, success being the combination of clinical cure and negative mycology at month 18. This criterion was used as the effectiveness measure in the pharmacoeconomic analysis, conducted from a payer perspective. RESULTS: In total, 249 patients were included into the study: 120 in the AT group and 129 in the T group. A significantly higher success rate was observed for patients in the AT group relative to those in the T group at 18 months (59.2% vs. 45.0%; P = 0.03). Both treatment regimens were safe and well tolerated. Treatment cost per cured patient was lower for the combination than for terbinafine alone in all countries. CONCLUSIONS: Study results confirmed that, in the treatment of dermatophytic toenail onychomycosis with matrix involvement, amorolfine nail lacquer in combination with oral terbinafine enhances clinical efficacy and is more cost-effective than terbinafine alone.
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| 3. |
- Baran, Robert, et al.
(författare)
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Superficial white onychomycosis--a syndrome with different fungal causes and paths of infection.
- 2007
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Ingår i: Journal of the American Academy of Dermatology. - : Elsevier BV. - 1097-6787 .- 0190-9622. ; 57:5, s. 879-82
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Tidskriftsartikel (refereegranskat)abstract
- Superficial white onychomycosis (SWO) is a clinical term used to describe onychomycosis in which the invasion of the nail plate occurs from the dorsal surface. However, recent observations indicate that the clinical appearances may vary to include infection in patches or in a striate patter. This report shows that, in some cases, it may be combined with either distal and lateral subungual onychomycosis or proximal white subungual onychomycosis. Invasion of the dorsal nail surface, but originating from the proximal nail fold, is another route of infection in SWO. A new classification of this condition is proposed with 4 main variants. Although based on clinical features, often other factors such as immunosuppression or invading organism (eg, Trichophyton rubrum or Fusarium species) appear to play a role in the development of a particular pattern of infection. This is an observational study carried out by trained and experienced clinicians. The main clinical implication is that in combined forms, or where the infection emerges from beneath the proximal nailfold, systemic rather than topical antifungal therapy is advised.
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| 4. |
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| 5. |
- Busch, R., et al.
(författare)
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Therapeutic effect of 1,5-pentanediol for herpes simplex labialis: a randomized, double-blind, placebo-controlled clinical trial
- 2009
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Ingår i: Advances in Therapy. - : Springer Science and Business Media LLC. - 0741-238X .- 1865-8652. ; 26:7, s. 719-27
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Most episodes of recurrent herpes labialis are self-limited and mild, but can be troublesome when they occur frequently with painful and unsightly lesions. Therefore, there has been much interest in developing agents that can suppress outbreaks in addition to being therapeutically effective. The objective of the present study was to examine the prophylactic and therapeutic efficacy of 1,5-pentanediol (PD) gel in patients with recurrent episodes of herpes labialis. METHODS: In this placebo-controlled, randomized, double-blind clinical trial, a total of 105 patients with frequent episodes of recurrent herpes were randomized to either PD or placebo. During the 26-week prophylactic phase of the study, the patients applied PD gel or placebo gel twice daily to both lips. Upon recurrence of an episode, a 5-day therapy phase started during which the gel was to be applied eight times daily. After the therapy phase, the patient resumed prophylactic treatment twice daily until the next herpes episode. The main outcome measures were number of herpes episodes during the prophylactic phase of 26 weeks, and successful therapy of occurring herpes episodes with a 5-day treatment. RESULTS: There was no significant difference in recurrence rate between the two groups (P>0.05). During recurrence there was a statistically significant improvement regarding the therapeutic effect of the symptoms "blistering," "swelling," and "pain" in the PD group. The global evaluation of efficacy by the investigators and patients showed a statistically significant superiority for PD as opposed to placebo (P<0.001). CONCLUSION: Under the conditions used in the present study, PD did not show any prophylactic effect against recurrence of herpes episodes. A significantly better therapeutic effect of PD over placebo could be demonstrated on the symptoms "blistering," "swelling," and "pain." PD was very safe as no side effects were observed during the course of the study.
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| 6. |
- Correia, O., et al.
(författare)
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Clinical trial design--towards better practices
- 2005
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Ingår i: J Eur Acad Dermatol Venereol. ; 19 Suppl 1, s. 40-2
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To review methodological approaches used in recent publications in onychomycosis clinical research. To identify key methodological criteria to ensure conclusive and reliable clinical results. METHODS: A Medline search for recent articles on onychomycosis treatment revealed considerable variation in inclusion criteria, definitions and methodology, rendering comparisons difficult. RESULTS: Careful diagnosis at trial entry is critical and predisposing factors affecting overall results are rarely considered at enrolment. Clear definitions are required, notably for the terms mycological, clinical and total cure. A consensus was reached that only studies that are evidence-based, controlled and double-blind with less than 10-15% of patients lost to follow-up should be accepted. Results should be interpreted with caution if a given treatment is found to be less effective than previously reported, even if the results are published in a recognized journal. It was agreed that an explanatory/pilot study should be done initially to determine whether there is a reason to believe that a new therapy is effective. If promising results are obtained, a double-blind, randomized study comparing the new therapy with either an existing therapy (preferably) or a placebo may be initiated. CONCLUSIONS: Sample size, and inclusion and exclusion criteria should be clearly determined. Efficacy criteria should include mycological, clinical and total cure rates. Finally, studies of toenail and fingernail onychomycosis must last at least 18 and 9 months, respectively.
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| 7. |
- Evenbratt, Hanne, 1980, et al.
(författare)
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Effect of pentane-1,5-diol and propane-1,2-diol on percutaneous absorption of terbinafine
- 2009
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Ingår i: Acta Dermato Venereologica. - 0001-5555 .- 1651-2057. ; 89:2, s. 126-9
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to compare pentane-1,5-diol and propane-1,2-diol used as absorption enhancers for cutaneously administered terbinafine. Fresh human skin samples were placed in a continuous flow diffusion cell with a gel containing terbinafine on top of the skin. Receptor fluid samples were analysed using high - performance liquid chromatography. The quantity of gel remaining on the skin surface after completion of each test was weighed and the amount of drug in the skin was analysed. Addition of pentane-1,5-diol or propane-1,2-diol to the gel increased the percutaneous absorption of the drug. The most efficient absorption enhancer in this comparison was 5% pentane-1,5-diol.
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| 8. |
- Faergemann, Jan, 1948, et al.
(författare)
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A double-blind, randomized, placebo-controlled, dose-finding study of oral pramiconazole in the treatment of pityriasis versicolor
- 2009
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Ingår i: Journal of the American Academy of Dermatology. - : Elsevier BV. - 1097-6787 .- 0190-9622. ; 61:6, s. 971-976
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Pramiconazole is a broad-spectrum triazole antifungal with potential for oral treatment of pityriasis versicolor. OBJECTIVE: We sought to assess the efficacy and tolerability of 5 doses of pramiconazole relative to placebo. METHODS: This was a randomized, multicenter, double-blind, placebo-controlled, 28-day, dose-finding study. A total of 147 patients were randomized to treatment with placebo or one of 5 doses of pramiconazole; treatment lasted for 3 consecutive days. Efficacy was based on mycological response, severity of clinical signs and symptoms, and the Investigator Global Assessment of lesion clearance. RESULTS: A statistically significant (P < .001) dose-dependent effect was observed. When compared with placebo, a significant response (P < .05) was obtained for all but the lowest single dose of pramiconazole. There were no serious, treatment-related adverse events or other safety concerns. LIMITATIONS: The follow-up period was limited to 1 month after treatment onset. CONCLUSIONS: Pramiconazole is a well-tolerated and effective treatment for pityriasis versicolor and the most effective treatment regimen in this study included 200 or 400 mg taken once, and 200 mg taken once daily for 2 or 3 days.
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| 9. |
- Faergemann, Jan, 1948, et al.
(författare)
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A new ketoconazole topical gel formulation in seborrhoeic dermatitis: an updated review of the mechanism
- 2007
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Ingår i: Expert Opin Pharmacother. ; 8:9, s. 1365-71
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Tidskriftsartikel (refereegranskat)abstract
- Seborrhoeic dermatitis (SD) is a chronic, inflammatory skin disorder, affecting areas of the head and body where sebaceous glands are most prominent and active. The disorder commonly affects hair-bearing areas of the head, including the scalp. Involvement on the face is usually limited to the hairline, eyebrows, nasolabial folds and ears, and may occur either with or without scalp involvement. Areas of the trunk where SD may occur include the body folds and the presternal area. The aetiology of SD is unknown, although hormones and the Malassezia spp., formerly known as Pityrosporum (naturally occurring yeasts), are thought to be involved in the development of the condition. SD responds to the use of antifungal medications such as ketoconazole, suggesting that the inflammation could be linked to the Malassezia spp. The mechanisms behind the therapeutic effect of ketoconazole for the management of SD form the basis of this review. The broad spectrum activity of Ketoconazole was reported in the early 1980s. Due to its potent effect against Malassezia spp. the development of ketoconazole for the treatment of various skin infections, in which a link was proposed with Malassezia spp., was initiated. Later on, a number of ancillary properties were described for ketoconazole, comprising antibacterial, anti-inflammatory, sebostatic and antiproliferative effects. The incorporation of ketoconazole in an adapted vehicle further promoted its efficacy. Recently, a new anhydrous gel containing 2% ketoconazole (Xolegel) was launched, in which all of the above properties were optimised.
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| 10. |
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