[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100144287":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":11,"locations":23,"responsibleParty":84,"collaborators":11,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":109,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Galderma Brasil Ltda.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adapalene-BPO Gel","EXPERIMENTAL",null,[13],"Drug: Adapalene-BPO Gel",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Apply 1 gram of the investigational drug every night on whole face.",[9],[20],{"name":21,"affiliation":5,"role":22},"Alessandra T Nogueira, MD","STUDY_DIRECTOR",[24,37,47,57,66,76],{"facility":25,"status":11,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":11},"Serviço de Dermatologia do Ambulatório Magalhães Neto do Complexo HUPES - Universidade Federal da Bahia","Salvador","Estado de Bahia","40110-160","Brazil","BR",{"type":32,"coordinates":33},"Point",[34,35],-38.49096,-12.97563,{"lat":35,"lon":34},{"facility":38,"status":11,"city":39,"state":40,"zip":41,"country":29,"countryCode":30,"cosmosGeoPoint":42,"geoPoint":46,"contacts":11},"Instituo da Pele","Goiânia","Goiás","74125-010",{"type":32,"coordinates":43},[44,45],-49.25389,-16.67861,{"lat":45,"lon":44},{"facility":48,"status":11,"city":49,"state":50,"zip":51,"country":29,"countryCode":30,"cosmosGeoPoint":52,"geoPoint":56,"contacts":11},"Hospital De Clínicas - Universidade Federal do Paraná","Curitiba","Paraná","80060-900",{"type":32,"coordinates":53},[54,55],-49.27306,-25.42778,{"lat":55,"lon":54},{"facility":58,"status":11,"city":59,"state":59,"zip":60,"country":29,"countryCode":30,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"Instituto de Dermatologia e Estética do Brasil Ltda.","Rio de Janeiro","22470-220",{"type":32,"coordinates":62},[63,64],-43.18223,-22.90642,{"lat":64,"lon":63},{"facility":67,"status":11,"city":68,"state":69,"zip":70,"country":29,"countryCode":30,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"KOLderma Instituto de Pesquisa Clínica Ltda","Campinas","São Paulo","13020-100",{"type":32,"coordinates":72},[73,74],-47.06083,-22.90556,{"lat":74,"lon":73},{"facility":77,"status":11,"city":69,"state":69,"zip":78,"country":29,"countryCode":30,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"Instituto de Assistência Médica ao Servidor Público Estadual","02404-020",{"type":32,"coordinates":80},[81,82],-46.63611,-23.5475,{"lat":82,"lon":81},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":85,"oldOrganization":5},"Alessandra Nogueira, MD","100144287","phase-4-evaluation-of-efficacy-and-safety-of-adapalene-01benzoyl-peroxide-25-gel-in-the-treatment-of-acne-vulgaris-100144287",false,"NCT01149330","Evaluation of Efficacy and Safety of Adapalene 0.1%\u002FBenzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris","Evaluation of Efficacy and Safety of Adapalene 0.1% \u002F Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris","Estudo Epiduo","Inclusion Criteria:\n\n* Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4),\n* Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose,\n* Subjects with a minimum of 30 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose,\n* Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study: oral\u002Fsystemic \\[injectable, patch…\\] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,\n* Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study,\n* Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure,\n* Subjects willing and capable of cooperating to the extend and degree required by the protocol.\n\nExclusion Criteria:\n\n* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment,\n* Female Subjects who are pregnant, nursing or planning a pregnancy during the study,\n* Subjects with more than 1 nodule or cyst on the face\n* Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.),\n* Subjects with known or suspected allergy to one of the investigational products (see package insert and\u002For investigator brochure),\n* Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc.\n* Subjects with a beard or other facial hair that might interfere with study assessments,\n* Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...)\n* Female subjects with a history of hormonal changes.\n* Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria:\n\n  * Topical treatment for acne in the past two weeks.\n  * Anti-inflammatory topic in the last two weeks.\n  * Use of topical corticosteroids on the face in the last four weeks.\n  * Anti-inflammatory systemic (hormonal or not) in the last four weeks.\n  * Use of systemic corticosteroids in the last four weeks.\n  * Systemic antibiotics in the last four weeks (excluding penicillins).\n  * Systemic retinoids in the last six months.\n  * Other systemic anti-acne the last four weeks.\n  * Anticonceptional oral used exclusively for the control of acne in the past six months.\n  * Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks.\n  * Cosmetic procedures such as PDT in the last four weeks.","ALL","12 Years","35 Years",{"count":98,"type":99},75,"ACTUAL","INTERVENTIONAL",[102],"PHASE4","The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%\u002FBenzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.",[105],"Acne Vulgaris",[107,108,105],"Adapalene","Benzoyl Peroxide","COMPLETED","2012-03-09",{"date":112,"type":113},"2012-03-12","ESTIMATED",{"date":115,"type":11},"2010-07",{"date":117,"type":99},"2011-04",{"name":5,"class":6},6]