[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100152505":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":25,"locations":33,"responsibleParty":45,"collaborators":25,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":25,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":25,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug 1","EXPERIMENTAL","Penciclovir 10mg\u002Fg",[13],"Drug: Penciclovir 10mg\u002Fg",{"label":15,"type":16,"description":17,"interventionNames":18},"Drug 2","ACTIVE_COMPARATOR","Acyclovir 50mg\u002Fg",[19],"Drug: Acyclovir 50mg\u002Fg",[21,26],{"type":22,"name":17,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Cream, dose 5 times daily during 5 days",[15],null,{"type":22,"name":11,"description":23,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"affiliation":31,"role":32},"Flavia Addor, MD","Medcin Instituto da Pele Ltda","PRINCIPAL_INVESTIGATOR",[34],{"facility":35,"status":25,"city":36,"state":36,"zip":25,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":25},"Flavia Addor","São Paulo","Brazil","BR",{"type":40,"coordinates":41},"Point",[42,43],-46.63611,-23.5475,{"lat":43,"lon":42},{"type":46,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100152505","phase-3-non-inferiority-comparison-of-efficacy-and-safety-of-penciclovir-10mgg-to-acyclovir-50mgg-in-the-treatment-of-recurrent-herpes-labialis-100152505",false,"NCT01257074","Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg\u002Fg to Acyclovir 50mg\u002Fg in the Treatment of Recurrent Herpes Labialis","A Randomized, Double-Blind, to Compare Non-inferiority Efficacy and Safety of Penciclovir 10mg\u002Fg to Acyclovir 50mg\u002Fg in the Treatment of Recurrent Herpes Labialis.","Inclusion Criteria:\n\n1. Patients must be able to understand the study procedures agree to participate and give written consent.\n2. Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs \u002F symptoms in the last 12-24 hours;\n3. No history of reaction to topical products;\n\nExclusion Criteria:\n\n1. Pregnancy or risk of pregnancy.\n2. Lactation\n3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)\n4. Sunlight over exposure in the last 15 days.\n5. Any pathology or past medical condition that can interfere with this protocol.\n6. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);\n7. Patients with immunodeficiency and\u002For immunosuppressive disease;\n8. Sunlight exposure in the last 15 days;\n9. Hypersensitivity to components of the formula;\n10. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.","ALL","18 Years",{"count":57,"type":58},76,"ACTUAL","INTERVENTIONAL",[61],"PHASE3","Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg\u002Fg as treatment for Herpes Labialis in comparison to acyclovir 50mg\u002Fg.",[64],"Herpes Labialis",[66],"Herpes Simplex","COMPLETED","2013-03-01",{"date":70,"type":71},"2013-03-04","ESTIMATED",{"date":73,"type":25},"2012-02",{"date":75,"type":58},"2012-10",{"name":5,"class":6},1]