[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353544":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":49,"responsibleParty":66,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":30,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Centre for Human Drug Research, Netherlands","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Erythromycin 4%","EXPERIMENTAL","Erythromycin 4% topical gel formulation, BID, 4 weeks",[13],"Drug: Erythromycin 4% topical gel formulation",{"label":15,"type":10,"description":16,"interventionNames":17},"Clindamycin 1%","Clindamycin 1% topical lotion formulation, BID, 4 weeks",[18],"Drug: Clindamycin 1% topical lotion formulation",{"label":20,"type":21,"description":22,"interventionNames":23},"ethanol solution","PLACEBO_COMPARATOR","70% topical ethanol solution, BID, 4 weeks",[24],"Drug: 70% topical ethanol solution",[26,31,34],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","Erythromycin 4% topical gel formulation",[9],null,{"type":27,"name":32,"description":16,"armGroupLabels":33,"otherNames":30},"Clindamycin 1% topical lotion formulation",[15],{"type":27,"name":35,"description":22,"armGroupLabels":36,"otherNames":30},"70% topical ethanol solution",[20],[38],{"name":39,"affiliation":40,"role":41},"Robert Rissmann, PharmD, PhD","CHDR","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":30,"email":46},"CONTACT","+31 71 5246 400","clintrials@chdr.nl",{"name":48,"role":44,"phone":45,"phoneExt":30,"email":46},"Diana Noort",[50],{"facility":51,"status":52,"city":53,"state":30,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Centre for Human Drug Research","RECRUITING","Leiden","2333 CL","Netherlands","NL",{"type":58,"coordinates":59},"Point",[60,61],4.49306,52.15833,{"lat":61,"lon":60},[64,65],{"name":39,"role":44,"phone":45,"phoneExt":30,"email":46},{"name":48,"role":44,"phone":45,"phoneExt":30,"email":46},{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[69],{"name":70,"class":71},"Maruho Co., Ltd.","INDUSTRY","100353544","phase-4-anti-inflammatory-effects-of-topical-erythromycin-and-clindamycin-in-acne-patients-100353544",false,"NCT03883269","Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients","A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne","Inclusion Criteria:\n\n1. Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;\n2. Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and\u002For pustules), present at screening and baseline visit\n3. A maximum of 5 nodules present at screening and baseline visit\n4. Inflammatory acne present for at least 6 months\n5. Fitzpatrick skin type I-II (Caucasian)\n6. Able and willing to give written informed consent and to comply with the study restrictions.\n7. Willing to comply with 2x2mm facial skin punch biopsies\n\nExclusion Criteria:\n\n1. Severe acne where systemic treatment is needed\n2. Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline\n3. Use of any oral\u002Fsystemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline\n4. Use of systemic isotretinoin within 6 months prior to baseline\n5. History of pathological scar formation (keloid, hypertrophic scar)\n6. Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.\n7. Known contact dermatitis reaction to any product\n8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.\n9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.\n10. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening\n11. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding",true,"ALL","18 Years","45 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.",[91],"Acne Vulgaris","2019-03-18",{"date":94,"type":95},"2019-03-20","ACTUAL",{"date":97,"type":95},"2018-03-20",{"date":99,"type":85},"2019-12",{"name":5,"class":6},1]