[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483503":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":43,"locations":62,"responsibleParty":119,"collaborators":43,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":43,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":43,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":43,"overallStatus":89,"whyStopped":43,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"NAOS Argentina S.A.","INDUSTRY",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational product (BI 479 V1)","ACTIVE_COMPARATOR","The study product or placebo will be applied twice daily on a clean and dry skin for 120 days. Follow \"3-6-9 method\" as follows: for babies (6 months to 24 months) use 3 pumps for the whole body (1 pump for face, 1 pump for trunk and arms and 1 pump for lower limbs), for children from 25 months: use 6 pumps for the whole body (1 pump for face, 3 pumps for trunk and arms and 2 pumps for lower limbs) and for children with height greater than 1.5 meters: use 9 pumps for the whole body (1 pump for face, 1 pump for chest, 1 pump for back, 1 pump per arm (x2) and 2 pumps per leg (x2). It will be applied from inclusion visit simultaneously with topical treatment in the following order: first the study product or placebo on the whole body followed by the topical treatment on the flare-up areas.",[13,14,15,16,17,18,19],"Other: Skin hydration","Other: Barrier function measurement","Other: Potential of hydrogen measurement (pH)","Other: Clinical evaluation of atopic dermatitis","Other: Quality of life assessment","Other: Assessment of the effect on itching and sleep disturbances","Other: Assessment of the tolerance of the study product or placebo",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo (BI 006)","PLACEBO_COMPARATOR","Same instructions of use as active comparator.",[13,14,15,16,17,18,19],[26,33,39,44,50,54,58],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"OTHER","Skin hydration","Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.",[9,21],[32],"Corneometer",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Barrier function measurement","TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.",[9,21],[38],"Transepidermal Water Loss (TEWL)",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Potential of hydrogen measurement (pH)","pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.",[9,21],null,{"type":27,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Clinical evaluation of atopic dermatitis","EASI score on each visit. Non invasive technique.",[9,21],[49],"Eczema Area and Severity Index (EASI)",{"type":27,"name":51,"description":52,"armGroupLabels":53,"otherNames":43},"Quality of life assessment","Cardiff questionnaires to assess quality of life of subjects and their family members.",[9,21],{"type":27,"name":55,"description":56,"armGroupLabels":57,"otherNames":43},"Assessment of the effect on itching and sleep disturbances","Visual analogue scale from 0 to 10",[9,21],{"type":27,"name":59,"description":60,"armGroupLabels":61,"otherNames":43},"Assessment of the tolerance of the study product or placebo","By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).",[9,21],[63,87,108],{"facility":64,"status":65,"city":66,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":43,"geoPoint":43,"contacts":70},"Cirec Latam","NOT_YET_RECRUITING","Ciudad Autónoma de Buenos Aire","1426","Argentina","AR",[71,76,80,83,85],{"name":72,"role":73,"phone":74,"phoneExt":43,"email":75},"Shantal Valdés, PhD","CONTACT","005491123465946","Shantal.Valdes@ar.naos.com",{"name":77,"role":73,"phone":78,"phoneExt":43,"email":79},"Alejandra Piegari, MD","005491164964851","alepiegari@gmail.com",{"name":81,"role":82,"phone":43,"phoneExt":43,"email":43},"Margarita Larralde, Prof","PRINCIPAL_INVESTIGATOR",{"name":77,"role":84,"phone":43,"phoneExt":43,"email":43},"SUB_INVESTIGATOR",{"name":86,"role":84,"phone":43,"phoneExt":43,"email":43},"Marisa Zocca, MD",{"facility":88,"status":89,"city":90,"state":43,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"CIDP","RECRUITING","New Delhi","110005","India","IN",{"type":95,"coordinates":96},"Point",[97,98],77.2148,28.62137,{"lat":98,"lon":97},[101,105,107],{"name":102,"role":73,"phone":103,"phoneExt":43,"email":104},"Kaur Sumit, MD","00911140793385","info@cidp-cro.com",{"name":106,"role":82,"phone":43,"phoneExt":43,"email":43},"Pranami Kashyap, MD",{"name":102,"role":84,"phone":43,"phoneExt":43,"email":43},{"facility":109,"status":110,"city":111,"state":111,"zip":112,"country":111,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":118,"contacts":43},"KK Women's & Children's Hospital","SUSPENDED","Singapore","179939","SG",{"type":95,"coordinates":115},[116,117],103.85007,1.28967,{"lat":117,"lon":116},{"type":120,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100483503","anti-relapse-efficacy-and-tolerance-assessment-of-a-cosmetic-cream-for-very-dry-irritated-to-atopic-sensitive-skin-100483503",false,"NCT05575882","Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream for Very Dry, Irritated to Atopic Sensitive Skin.","Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin","Inclusion Criteria:\n\n* General criteria:\n\nHealthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)\u002Flegal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents\u002Flegal representative(s) willing to adhere to the study protocol and procedures.\n\nSpecific criteria:\n\nSex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D0. Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and\u002For tacrolimus).\n\nExclusion Criteria:\n\n* Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)\u002Flegal representative(s) considered by the investigator to be likely not compliant to the protocol.","ALL","6 Months","15 Years",{"count":132,"type":133},100,"ESTIMATED","INTERVENTIONAL",[136],"NA","Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit \\[day (D) 0\\] and 4 follow-up visits (D30, D60, D90, and D120).",[139,140],"Atopic Dermatitis","Eczema, Atopic","2025-03-21",{"date":143,"type":144},"2025-03-25","ACTUAL",{"date":146,"type":144},"2022-11-03",{"date":148,"type":133},"2025-11",{"name":5,"class":6},3]