Evaluation of precursory gel of film containing on-site anesthetic for treatment of the herpes simplex: in vivo prospective cohort study

Abstract

Herpes labialis (HSV) is an ongoing public health problem worldwide, HSV viruses are highly contagious and reach between 20 and 40% of the population. Type 1 HSV is associated more often orofacial lesions, the disease has no cure and remains dormant for life, manifesting itself in periods of weakness of the body, reaching populations without preference for race, gender or age. For the treatment and control of this health problem, a multidisciplinary approach is necessary in order to remission of symptoms more quickly than with conventional antiviral treatments, as well as patients' biopsychosocial discomfort. This project aims to evaluate the effectiveness of the gel precursor of the in situ film formation for the treatment of labial herpes lesions. For this, one gel was proposed whose active ingredient is a mixture of anesthetics: lidocaine and prilocaine, whose properties are different and comprise anti-inflammatory, antimicrobial and antiviral activity. They will be invited to participate in the study, legal adults or minors with legal authorization subjects with HSV-1, both genders, immunocompetent, including smokers and drinkers. Individuals will be excluded in use or used specific antiviral medication, local or systemic, in the 15 days preceding the study, will be excluded from the study, as well as pregnant women and patients with heart disease. The subjects will be invited to participate in the study through an announcement on Radio USP site, invitations in social networks, e-mails and posters in units of USP / RP. By accepting, they will sign a Consent and Informed (IC) and fill out a online form registration in the search, and receive information where to look for the researcher as well to realize the first Herpes manifestation of symptoms for which the drug will be applicated. The treatment consists of three applications of film precursor gel loaded with anesthetic salt, one at time zero and every other each 08 hours. In each time a gel containing 30mg dose of the anesthetic mixture is applied and spread in the region where the herpetic lesion. They will be captured images at time zero and 72 hours in order to register the clinical improvement in terms of objective signs. The subject will be followed for 6 months, with bimonthly connections and / or spontaneous returns with reapplication of treatment every relapse, answering questionnaires about satisfaction, action treatment, aspects of formulation among other topics. After 6 months, it is available to the research subject seek the services and treatments the group as WIC. This project is already approved by the Research Ethics Committee of FORP via Platform Brazil, by CAAE Protocol: 45356915.6.0000.5419.