[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581071":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":47,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Puerto Rico","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Participants received oral metformin tablets, starting at 500 mg once daily. At week 4, those who tolerated the medication increased to 500 mg twice daily for the remainder of the study.",[13],"Drug: Metformin",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants received oral metformin tablets for the treatment of melasma. The initial dose was 500 mg once daily for four weeks. At week 4, participants who tolerated the medication well increased their dose to 500 mg twice daily for the remaining eight weeks of the study. Participants were instructed to avoid other melasma treatments during the trial and to use sunscreen (SPF 30 or higher) daily.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Cristina Brau","PRINCIPAL_INVESTIGATOR",[25,30],{"name":22,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","787-758-2525","5500","cbrau@skinbybrau.com",{"name":31,"role":26,"phone":19,"phoneExt":19,"email":32},"Camila Cordero","camila.cordero@upr.edu",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":38,"cosmosGeoPoint":41,"geoPoint":46,"contacts":19},"Administración de Servicios Médicos (ASEM) Clinicas Externas","RECRUITING","San Juan","PR","00935","Puerto Rico",{"type":42,"coordinates":43},"Point",[44,45],-66.10572,18.46633,{"lat":45,"lon":44},{"type":23,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Cristina Brau-Javier","MD, Associate Professor","100581071","phase-1-oral-metformin-for-treating-melasma-in-latin-american-women-100581071",false,"NCT06845540","Oral Metformin for Treating Melasma in Latin American Women","Oral Metformin in the Treatment of Melasma: a Prospective Trial in Latin American Women","Inclusion Criteria: Latin American women aged 21 years or older, diagnosed epidermal or mixed melasma\n\nExclusion Criteria: pregnancy, breastfeeding, use of hydroquinone or tretinoin within 2 months before the study, or undergoing laser treatment, peels, microdermabrasion, or microneedling within 2 months of the study. Patients with a history of renal or liver disease, metformin allergy, diabetes, hypoglycemia, or those on medications that could interact with metformin will also be excluded.","FEMALE","21 Years",{"count":60,"type":61},30,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","The goal of this clinical trial is to learn if metformin can treat melasma in Latin American women. The main question it aims to answer is:\n\n\\- Can metformin help reduce the dark patches of melasma?\n\nResearchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma.\n\nParticipants will:\n\n* Take a metformin pill every day for three months.\n* Go to the clinic twice: once at the beginning and once at the end of the study.\n* Get a phone call from the researchers to check how they're doing and ask about any changes or side effects.",[68],"Melasma",[70,71],"melasma","metformin","2025-02-19",{"date":74,"type":75},"2025-02-25","ACTUAL",{"date":77,"type":61},"2025-02-20",{"date":79,"type":61},"2025-05-30",{"name":5,"class":6},1]