[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502577":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":35,"locations":41,"responsibleParty":53,"collaborators":28,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":28,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":28,"overallStatus":75,"whyStopped":28,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"OMA102 1 mg","EXPERIMENTAL","Ingestion of 1 oral tablet, once a day, immediately before lying down to sleep",[13],"Drug: OMA102",{"label":15,"type":10,"description":11,"interventionNames":16},"OMA102 2 mg",[13],{"label":18,"type":19,"description":11,"interventionNames":20},"Placebo","PLACEBO_COMPARATOR",[21],"Drug: Placebo",[23,29,32],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","OMA102","1 mg",[9],null,{"type":24,"name":25,"description":30,"armGroupLabels":31,"otherNames":28},"2 mg",[15],{"type":24,"name":18,"description":33,"armGroupLabels":34,"otherNames":28},"OMA102 - Placebo",[18],[36],{"name":37,"role":38,"phone":39,"phoneExt":28,"email":40},"Cassiano Ricardo O Berto, B.S.","CONTACT","+551938877724","pesquisa.clinica@ncfarma.com.br",[42],{"facility":5,"status":28,"city":43,"state":44,"zip":28,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":28},"Hortolândia","São Paulo","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-47.22,-22.85833,{"lat":51,"lon":50},{"type":54,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100502577","phase-3-efficacy-and-safety-of-oma102-in-the-treatment-of-female-pattern-hair-loss-100502577",false,"NCT05824065","Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss","Phase III, National, Multicenter, Randomized, Double-Blind, Superiority Clinical Trial to Evaluate the Efficacy and Safety of OMA102 in the Treatment of Female Pattern Hair Loss","GENERA","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Age greater than 18 and equal or under 50 years;\n* Confirmed diagnosis of female pattern hair loss, grade II to IV in Sinclair Scale;\n* Participants that are disposed to maintain the same hair color, style, approximate hair length throughout the Clinical Study.\n\nExclusion Criteria:\n\n* Any clinical or physical finding interpreted by the investigator as a risk to subject participation in the Clinical Study\n* History of alcohol or illicit drugs abuse in the last year;\n* Pregnant or breastfeeding women, who are planning to become pregnant or participants who have childbearing potential and are not using any reliable contraceptive method;\n* Allergy or sensibility to any knowing components of the formula;\n* Diagnosis of arterial hypertension;\n* History of vasovagal syncope;\n* Baseline systolic blood pressure lower than 90 mmHg and\u002For diastolic lower than 60 mmHg;\n* Diagnosis of orthostatic hypotension (reduction of systolic blood pressure equal or superior to 20 mmHg and\u002For diastolic equal or superior to 10 mmHg after 3 minutes in orthostatic position);\n* Body mass index (BMI) \\> 30 kg\u002Fm²;\n* Subjects that initiated any kind of continue use medication, including contraceptives with systemic effect, until 3 months previously the inclusion in the Clinical Study;\n* History of cardiovascular, liver and renal diseases;\n* History of hypothyroidism, hyperthyroidism or pheochromocytoma;\n* Signs or symptoms of cardiopathy or angina;\n* History of edema from any etiology;\n* Participants who are using tricycle antidepressants, benzodiazepines, antipsychotics, anticholinergics, sulfonamide derivatives, beta-blockers, sympathomimetics, arginine, glucocorticoid or monoamine oxidase inhibitors;\n* Use of inhibitor of 5-alpha reductase or androgenic blockers in the last 12 months;\n* Dermatologic diseases of the scalp, except mild seborrheic dermatitis or diagnosis of any kind of alopecia other than female pattern hair loss;\n* History of surgical treatment for hair loss or presence of shaved scalp;\n* Scalp microinfusion, microneedling or intradermotherapy in the last 3 years;\n* Vaginal or cesarean deliveries 6 months before the inclusion in the study;\n* Drastic modification of habitual diet, as food restrictions or hyperselectivity;\n* Current cancer or history of cancer in the last 5 years;\n* Participation in others research protocols in the last 12 months, unless the investigator judges that there may be a direct benefit to the participant.","FEMALE","18 Years","50 Years",{"count":67,"type":68},504,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","The goal of this clinical trial is to evaluate the efficacy and safety of OMA102 1 mg and OMA102 2 mg versus placebo in the treatment of female pattern hair loss.",[74],"Female Pattern Baldness","NOT_YET_RECRUITING","2024-02-15",{"date":78,"type":79},"2024-02-16","ACTUAL",{"date":81,"type":68},"2025-01",{"date":83,"type":68},"2027-01",{"name":5,"class":6},1]