[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385619":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":20,"responsibleParty":90,"collaborators":10,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":10,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":10,"overallStatus":109,"whyStopped":10,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Pierre Fabre Dermo Cosmetique","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RV3278A arm",null,"study product RV3278A is applied twice a day on the face during the whole study.\n\nIn case of reaction resulting from the use of the product, the subject will inform the investigator who will explain to him\u002Fher what to do : application reduction or stop applications for a while",[13],"Other: RV3278A",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"OTHER","RV3278A","RV3278A is a non-rinsed cosmetic cream intended to be used every day on adolescents and young adults with acne-prone skin.",[9],[21,33,42,51,62,70,80,85],{"facility":22,"status":10,"city":23,"state":10,"zip":24,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":10},"Centre de Santé Sabouraud - Hôpital Saint Louis","Paris","75010","France","FR",{"type":28,"coordinates":29},"Point",[30,31],2.3488,48.85341,{"lat":31,"lon":30},{"facility":34,"status":10,"city":35,"state":10,"zip":36,"country":25,"countryCode":26,"cosmosGeoPoint":37,"geoPoint":41,"contacts":10},"cabinet Médical","Sèvres","92310",{"type":28,"coordinates":38},[39,40],2.21757,48.82292,{"lat":40,"lon":39},{"facility":43,"status":10,"city":44,"state":10,"zip":45,"country":25,"countryCode":26,"cosmosGeoPoint":46,"geoPoint":50,"contacts":10},"Skin Research Centre","Toulouse","31300",{"type":28,"coordinates":47},[48,49],1.44367,43.60426,{"lat":49,"lon":48},{"facility":52,"status":10,"city":53,"state":10,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":10},"Medical Office","Milan","20124","Italy","IT",{"type":28,"coordinates":58},[59,60],12.59836,42.78235,{"lat":60,"lon":59},{"facility":52,"status":10,"city":63,"state":10,"zip":64,"country":55,"countryCode":56,"cosmosGeoPoint":65,"geoPoint":69,"contacts":10},"Pavia","27100",{"type":28,"coordinates":66},[67,68],9.15917,45.19205,{"lat":68,"lon":67},{"facility":52,"status":10,"city":71,"state":10,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":10},"Warsaw","01-817","Poland","PL",{"type":28,"coordinates":76},[77,78],21.01178,52.22977,{"lat":78,"lon":77},{"facility":52,"status":10,"city":71,"state":10,"zip":81,"country":73,"countryCode":74,"cosmosGeoPoint":82,"geoPoint":84,"contacts":10},"02-625",{"type":28,"coordinates":83},[77,78],{"lat":78,"lon":77},{"facility":52,"status":10,"city":71,"state":10,"zip":86,"country":73,"countryCode":74,"cosmosGeoPoint":87,"geoPoint":89,"contacts":10},"08-818",{"type":28,"coordinates":88},[77,78],{"lat":78,"lon":77},{"type":91,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100385619","assess-the-effects-and-the-tolerance-of-cosmetic-product-in-the-follow-up-phase-of-facial-acne-for-1-year-100385619",false,"NCT04301063","Assess the Effects and the Tolerance of Cosmetic Product in the Follow-up Phase of Facial Acne for 1 Year","An International Multicentric Open-label Descriptive Study to Assess the Effects and Evaluate the Tolerance of the Cosmetic Care Product RV3278A in the Follow-up Phase of Facial Acne in Teenagers and Young Adults for 1 Year","Inclusion Criteria:\n\nCriteria related to the population:\n\n* Female or male aged between 12 and 35 years included\n* Phototype I, II, III or IV according to Fitzpatrick classification\n* For major subject:\n\n  o Subject who has signed his\u002Fher written informed consent for his\u002Fher participation in the study\n* For minor subject:\n\n  o Subject and\u002For parent(s)\u002Flegal representative(s), according to national regulations, who have signed his\u002Fher written informed consent for subject's participation in the study\n* If required by national regulations, subject must be registered with health social security or health social insurance\n* Woman of childbearing potential:\n\n  o use of an effective contraceptive method, as assessed by the investigator, for at least 3 months before the inclusion, accepting to go on using this method during the whole duration of the study\n* Subject or parent (s) \u002F guardian(s) owning a smartphone with adequate parameters to download the application (including having enough storage space, a version of android or iOS compatible with the application) and a web access\n\nRelated to the diseases and skin condition:\n\n* Subject with oily skin\n* Subject with dilated pores on the forehead\n* Almost clear, mild or moderate facial acne with score index severity GEA=1 (almost clear), GEA=2 (mild) or GEA=3 (moderate) assessed on a scale ranged from 0 to 5.\n\nExclusion Criteria:\n\nRelated to the population:\n\n* Subject who is unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his\u002F her consent to participate\n* Subject who is currently participating, plans to participate or has participated in another clinical study prior to inclusion visit, liable to interfere with the study assessments according to the investigator\n* For woman of childbearing potential: subject pregnant or breastfeeding or planning to be pregnant during the study\n* Subject deprived of freedom by administrative or legal decision or under guardianship\n* Subject who, in the judgement of the investigator, is not likely to be compliant with study-related requirements\n* Subject who is a family member of the investigator or any associate, colleague, employee assisting in the conduct of the study ( secretary, nurse, technician…)\n\nRelated to the disease:\n\n* Severe type of acne (Acne conglobata, Acne fulminans or nodulocystic acne) or acneiform induced eruptions according to investigator's assessment\n* Facial skin pathology other than acne, skin abnormalities or dermatological condition on the face liable to interfere with the study assessments (including psoriasis, atopic dermatitis, skin infectious disease of viral, bacterial, fungus or parasitic origin …)\n* Forehead scars in tested area liable to interfere with samples realisation (cyanoacrylate stripping)\n* Acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments\n* Clinical signs of hormonal dysfunctions or hyperandrogenism\n* History of allergy or intolerance to any cosmetic product, to the investigational product ingredients or to cyanoacrylate\n* Solar erythema on the face due to excessive UV exposure\n\nRelated to the treatments\u002Fproducts:\n\n* Any surgery, chemical or physical treatment on the experimental area done within 6 months before the inclusion or planned during the study\n* Oral intake of isotretinoin within 6 months before the inclusion\n* Hormonal contraception or hormonal antic-acne treatment established or modified within 3 months before the inclusion or planned to be established or modified during the study\n* Any oral or topical anti-acne treatment taken\u002Fapplied on the face within 1 month before the inclusion\n* Use of topical or systemic treatment during the previous weeks or ongoing, liable to interfere with the assessment of the cutaneous tolerance and effects of the studied product (according to the investigator's appreciation)\n* Facial cleansing or skin care product containing anti-acne or keratolytic ingredients applied within 15 days before the inclusion or planned to be applied during the study\n* Facial cleansing or skin care product (including moisturizer, make-up remover, foundation cream\u002Fpowder) established or modified within 15 days before the inclusion\n* Any rinsed\u002Fnon-rinsed skin care product (including moisturizer and sunscreen), make-up (including foundation cream\u002Fpowder) or make-up remover applied on the face (including eyes and mouth) the day of the inclusion visit","ALL","18 Years","35 Years",{"count":103,"type":104},54,"ACTUAL","OBSERVATIONAL","Acne is a chronic inflammatory disease of the pilo-sebaceous unit in the skin. Indeed, your skin is covered with tiny holes called hair follicles, or pores. These pores contain sebaceous glands (also called oil glands) that make sebum, an oil that moistens your hair and skin. Most of the time, the glands make the right amount of sebum and the pores are fine. But sometimes a pore gets clogged up with too much sebum, dead skin cells, and germs called bacteria. This can cause acne.\n\nPierre Fabre Laboratories have developed a cosmetic care product, a cream which is commercialized since September 2019. This leave-on skin care product is adapted for acne-prone skin.\n\nIn this study, we are interested in the effects of this care product in facial acne evolution for 12 months (quality of life, acne severity, number of acne flares). Also, we are interested in the subject's satisfaction regarding the use of this care product. This study will also enable to know if the product is well tolerated in such application circumstances.\n\nThis clinical study will be carried out in 54 subjects (female or male), aged between 12 and 35 years, in about 10 centers in different European countries.\n\nThe maximal duration of the study for a subject will be 1 year. If you give your consent to take part in this study, you will receive a cosmetic care product, also called study product, that you will apply on your face twice a day (morning and evening) for the whole duration of the study.\n\nWhat makes this study original is the use of a smartphone application to help you to comply with the study procedures and to help the investigator to follow you.",[108],"Acne Vulgaris","COMPLETED","2021-04-01",{"date":112,"type":104},"2021-04-02",{"date":114,"type":104},"2019-02-04",{"date":116,"type":104},"2020-05-06",{"name":5,"class":6},8]