[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639880":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Hospital Israelita Albert Einstein","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants will receive a standardized facial skincare regimen to be used daily for 12 weeks, including a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen (non-investigational). Products will be used daily, with cleanser twice daily, moisturizer in the morning, serum at night, and sunscreen twice daily.\n\nParticipants will undergo evaluations at baseline, week 6, and week 12, including standardized photography and assessment using Hyperpigmentation Area Severity Scale (HASI) and Investigator's Global Assessment (IGA). Quality of life will be assessed with Melasma Quality of Life Scale (MelasQoL) and Dermatology Life Quality Index (DLQI). Participants will complete daily diaries to record product use and any reactions during the study, and will assess perceived product efficacy at the final visit.",[13],"Drug: Niacinamide and Bioceramide-Based Skincare Regimen",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Niacinamide and Bioceramide-Based Skincare Regimen","A standardized facial skincare regimen containing a cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen. The products are intended for daily use, with cleanser applied twice daily, moisturizer applied in the morning, serum applied at night, and sunscreen applied twice daily.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Bruna Cestari de Azevedo, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Jessica Andrade-Silva, PhD","CONTACT","+55975295921","jessica.as@einstein.br",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Camila Hernandes Pinheiro, PhD","+5511952960024","camila.hernandes@einstein.br",[36],{"facility":5,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","São Paulo","05652-900","Brazil","BR",{"type":43,"coordinates":44},"Point",[45,46],-46.63611,-23.5475,{"lat":46,"lon":45},[49,50,51],{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[55],{"name":56,"class":57},"COTY BRASIL COMERCIO S.A.","UNKNOWN","100639880","study-on-the-functional-impact-of-cosmetics-on-improving-self-esteem-and-quality-of-life-in-black-women-100639880",false,"NCT07618572","Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women","Inclusion Criteria:\n\n* Female participants aged 18 to 55 years\n* Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH)\n* Self-identified as Black (including \"preta\" or \"parda\")\n* Fitzpatrick skin types IV to VI\n* Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units\n* Willing and able to comply with all study procedures and attend all scheduled visits\n* Able and willing to provide written informed consent and authorization for image use\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or those planning pregnancy during the study period\n* Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma)\n* Known or suspected intolerance to similar cosmetic products\n* History of atopy or allergic reactions to cosmetic products\n* Personal or family history of skin cancer\n* Active skin conditions or lesions affecting the face\n* Facial marks or scars that may interfere with assessments\n* Skin irritation due to recent sun exposure\n* Excessive sun or UV exposure, including artificial tanning, within the past month\n* Use of facial cosmetic products within 7 days before screening\n* Use of topical or systemic treatments within 1 month before screening\n* Use of depigmentation treatments within 3 months before screening\n* Use of dermocosmetic treatments for PIH within 3 months before screening\n* Facial dermatological or aesthetic procedures within 2 weeks before screening\n* Use of corticosteroids, anticoagulants, or immunosuppressive drugs\n* Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7)\n* Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)","FEMALE","18 Years","55 Years",{"count":68,"type":69},60,"ESTIMATED","INTERVENTIONAL",[72],"NA","The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI).\n\nThe main questions it aims to answer are:\n\n* Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores?\n* Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires?\n\nParticipants will:\n\n* Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks.\n* Attend study visits at baseline, week 6, and week 12.\n* Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12.\n* Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.",[75],"Post-inflammatory Hyperpigmentation",[75,77,78,79,80],"Bioceramides","Niacinamide","Black Women","Facial Hyperpigmentation","2026-06-02",{"date":83,"type":84},"2026-06-04","ACTUAL",{"date":86,"type":84},"2026-03-19",{"date":88,"type":69},"2026-10-31",{"name":5,"class":6},1]