Background. Currently, onychomycosis is an urgent and widespread problem in dermatology. The defeat of the nail plates is the cause of a cosmetic defect and a decrease in the quality of life of patients. Systemic antimycotics are effective, but have a number of side effects when used. Thus, a modern and effective approach to the treatment of patients with this pathology is needed.
The aim of the study. To prove the efficacy, safety and tolerability of Ekzilak as local monotherapy of onychomycosis compared with cyclopyrox monotherapy.
Materials and methods. А randomized open-label study with active control included 172 outpatient subjects: men and women aged 18 to 75 years, with microscopically confirmed onychomycosis of the big toe (one or both feet), a superficial or distal form of onychomycosis with a lesion of no more than 1/3 of the nail length (KIOTOS from 1 to 6). Patients were randomized into two groups: the 1st group of patients applied Ekzilak locally daily for 6 months, the 2nd group of patients applied Ciclopirox nail lacquer topical solution 8% as follows: 1 time a day for the first month, 2 times a week for the second one and 1 time a week for the months third-sixth. The preparations were applied in a thin layer to the affected nail. The primary efficacy endpoint in the study was the proportion of patients who achieved complete recovery of the target toenail at the end of therapy (clinical + mycological recovery). Secondary endpoints included the proportion of patients who achieved clinical recovery after 6 months of treatment (clinical recovery is a complete restoration of the normal morphology of the affected nail), the proportion of patients who achieved mycological recovery (microscopy with KOH solution) after 3 months of treatment, the proportion of patients who achieved complete recovery of the target toenail in 4 weeks after the end of treatment; IGA (Investigator's Global Assessment), Integrated Medicine Patient Satisfaction Scale (IMPSS); the safety Analysis was carried out throughout the study and included an assessment of adverse events, laboratory data, vital signs.
Results. The results of the study showed that Ekzilak is superior in terms of efficacy to the registered drug Ciclopirox nail lacquer topical solution 8% as a local monotherapy of onychomycosis. The difference in the proportion of patients who achieved complete recovery between the study drug and the reference drug was 22.09%, 95% CI for the difference in the proportion was [8.21%; 35.97%], the differences between the groups are statistically significant (p=0.002). At the same time, the analysis of safety data, including the assessment of adverse events, laboratory studies and impact on vital signs, did not reveal statistically and clinically significant differences between the treatment groups.
Conclusions. New combination drug Ekzilak is an effective and safe treatment option for patients with onychomycosis.
The review presents modern literature data on the use of tacrolimus in medical practice. The results of national and international research on the effectiveness and safety of the drug at various dermatoses are presented.
Introduction. The systemic psoriatic process affects not only the skin, but also other organ systems, including the cardiovascular system. Immunopathological inflammation that occurs in the skin and articular tissues is a central link in the pathology of the cardiovascular system in psoriasis.Objective. Identify diseases of the cardiovascular system and factors of their development in patients with psoriasis and to assess their severity depending on the severity of dermatosis.Materials and methods. The study included 406 patients with psoriasis aged 18 to 74 years, who were divided into three subgroups depending on the severity of the course. Assessment of the state of the cardiovascular system was carried out using the following methods: uestionnaire, clinical, physical, laboratory and statistical. The comparison group consisted of 200 people.Results. In 53.9% of patients, psoriasis occurred against the background of cardiovascular comorbidity. More than 90% of patients with moderate to severe psoriasis have more than three risk factors for CCC diseases. Patients are more susceptible to the development of hypertension, hypercholesterolemia, obesity, abdominal obesity, stress and smoking. The higher the cardiovascular risk, the more severe psoriasis is.Conclusions. The presence of unmodified and modifiable risk factors for the development of cardiovascular diseases is aggravating for the course of psoriasis, which means that the risk of undesirable fatal events is higher. Patients with psoriasis need additional preventive measures aimed at preventing the development of cardiovascular pathology.
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