ABSTRACT
This was Phase III multicenter, double-blind, randomized, comparative safety and efficacy study in parallel groups of subjects, assessing non-inferiority between two commercially available otologic suspensions containing ciprofloxacin 2mg/mL and hydrocortisone 10mg/mL (Otociriax and Cipro HC®) in the treatment of acute diffuse otitis externa. Following screening and informed consent, subjects were randomly allocated into two treatment groups: Group A (treated with Otociriax) and Group B (treated with Cipro HC®). Treatment regimen in both groups was three drops, twice daily for seven days. The primary study endpoint was otitis cure, defined as elimination of pain, edema, and otorrhea. The secondary study endpoint was presence of side effects. Efficacy assessments included presence and intensity of otitis externa manifestations. Safety assessments included vital signs and physical examination, as well as adverse event monitoring. Study data analysis was performed using GraphPad Prism 5.0...
Subject(s)
Humans , Male , Female , Ciprofloxacin , Hydrocortisone , Otitis ExternaABSTRACT
Herpes é uma infecção causada por dois vírus da família Herpesviridae (herpes simples tipos 1 e 2; HSV-1 e HSV-1), que apresenta curso clínico variável e para o qual atualmente não existe cura. As manifestações da infecção por HSV-1 incluem herpes simples orofacial primário e recorrente, enquanto as do HSV-2 em geral ocorrem na forma de herpes simples genital, embora casos de lesões genitais pelo HSV-1 e orais pelo HSV-2 possam ocorrer. As infecções pelo vírus herpes simples (HSV-1 e HSV-2) representam as doenças sexualmente transmissíveis mais comuns a nível global, alcançando uma soroprevalência de 80% em adultos. Nesta revisão da literatura, abordaremos os aspectos clínicos da infecção pelo HSV, incluindo a epidemiologia, etiologia, manifestações clínicas, métodos diagnósticos e tratamento, bem como uma breve descrição da imunogenética da infecção pelo HSV
Herpes is an infection caused by two viruses in the Herpesviridae family (herpes simplex types 1 and 2; HSV-1 and HSV-2), which presents a variable clinical course and for which there is currently no cure. The manifestations of HSV-1 infection include primary and recurrent orofacial herpes simplex, while HSV-2 infection usually manifests in the form of genital herpes simplex, although cases of genital lesions from HSV-1 infection and oral lesions form HSV-2 infection can occur. Infections by the herpes simplex virus (HSV-1 and HSV-2) represent one of the most common sexually transmitted diseases globally, reaching a serum prevalence of 80% in adults. In this review of the literature, we discuss the clinical aspects of HSV infection, including epidemiology, etiology, clinical manifestations, diagnosis and treatment, as well as a brief description of the immunogenetics of HSV infection.
Subject(s)
Humans , Herpesvirus 1, Human , Herpes Simplex/diagnosis , Herpes Simplex/etiology , Herpes Simplex/therapy , Herpes Simplex/epidemiology , HLA Antigens , Sexually Transmitted Diseases , Major Histocompatibility ComplexABSTRACT
The primary objective of this double-blind, randomized, controlled clinical trial was to assess the use of azithromycin dihydrate in oral suspension form in the treatment of impetigo in children. The secondary objectives were to compare the efficacy and safety of two presentations of azithromycin dihydrate in the treatment of impetigo in children, on wound healing and on wound pruritus. After screening and obtaining informed consent of the parents or legal guardians, a total of 100 patients ranging in age from 2-8 years old and presenting impetigo were randomized to one of two groups for a 3-day treatment period using azithromycin dihydrate in oral suspension in single doses of 10mg/kg/day: Group A (manufactured by Merck S.A.), and Group B (manufactured by Pfizer). Patients returned to the study center at the end of the 3-day treatment (Visit 2) and 7 days after the Pretreatment visit (Visit 3) for efficacy assessments and safety monitoring. Pretreatment demographic data and impetigo characteristics (type, location, number of lesions, pruritus) were homogenous between treatment groups. At the end of the study, all patients in both groups presented either ?improvement? or ?cured? lesions, with the majority (72.9%) of the patients presenting ?cured? lesions. We observed a statistically significant decrease in pruritus severity at Visit 2 and Visit 3 in relation to pretreatment, with no significant between-group difference at either study visit. Reported adverse events were transient and mild-to moderate in severity in both treatment groups, with no serious adverse events reported during the study. Based on the data collected during this study, we conclude that the two presentations of azithromycin were safe and effective in the treatment of impetigo in the population evaluated.