[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656058":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":39,"studyPopulation":26,"armGroups":40,"interventions":53,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":298,"collaborators":26,"id":300,"slug":301,"hasResults":302,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":302,"sex":308,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":26,"studyType":314,"phases":315,"briefSummary":318,"conditions":319,"keywords":26,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},{"fullName":5,"class":6},"Pelage Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in non-vellus target area hair count","Change from baseline in non-vellus target area hair count (nvTAHC) at the vertex","Week 24",[14,17,21,23,24],{"measure":15,"description":16,"timeFrame":12},"Change from baseline in the Participant Assessment of Scalp Coverage","Change from baseline in the Participant Assessment of Scalp Coverage (PASC), where higher scores correspond to greater coverage",{"measure":18,"description":19,"timeFrame":20},"≥20% increase from baseline in non-vellus target area hair count","Proportion of participants with ≥20% increase from baseline in non-vellus target area hair count","week 24",{"measure":10,"description":11,"timeFrame":22},"Week 12",{"measure":15,"description":16,"timeFrame":22},{"measure":18,"description":19,"timeFrame":25},"week 12",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","Participants will be randomized (1:1) on Day 1 to one of the following two treatment sequences:\n\n1. PP405 from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52\n2. Vehicle from Day 1 to Week 24; then re-randomized 1:1 to either PP405 or vehicle from Week 24 to Week 52","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":34},"QUADRUPLE",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Participants will initially be randomized 1:1 to PP405 or vehicle and complete a 24 week double blinded treatment period. At Week 24, the PP405 group will continue PP405 treatment, and the vehicle group will be re-randomized 1:1 to PP405 or vehicle for the double-blind long term safety extension period through study week 52.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"PP405 0.05% Topical Gel","EXPERIMENTAL","PP405 applied to the scalp from Day 1 to Week 24; then continuing PP405 from Week 24 to Week 52.",[46],"Drug: PP405 0.05% Topical Gel",{"label":48,"type":49,"description":50,"interventionNames":51},"Vehicle Topical Gel","PLACEBO_COMPARATOR","Vehicle applied to the scalp from Day 1 to Week 24; then re-randomized 1:1 to receive either PP405 or vehicle QD from Week 24 to Week 52",[46,52],"Drug: Vehicle Topical Gel",[54,60],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Medicated topical gel containing PP405 0.05%",[42,48],[59],"PP405",{"type":55,"name":48,"description":61,"armGroupLabels":62,"otherNames":63},"Topical 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Smith","Arkansas","72916",{"type":86,"coordinates":97},[98,99],-94.39855,35.38592,{"lat":99,"lon":98},{"facility":102,"status":79,"city":103,"state":94,"zip":104,"country":83,"countryCode":84,"cosmosGeoPoint":105,"geoPoint":109,"contacts":26},"Burke Pharmaceutical Research","Hot Springs","71913",{"type":86,"coordinates":106},[107,108],-93.05518,34.5037,{"lat":108,"lon":107},{"facility":111,"status":79,"city":112,"state":113,"zip":114,"country":83,"countryCode":84,"cosmosGeoPoint":115,"geoPoint":119,"contacts":26},"Ablon Skin Institute and Research Center","Manhattan Beach","California","90266",{"type":86,"coordinates":116},[117,118],-118.41091,33.88474,{"lat":118,"lon":117},{"facility":121,"status":79,"city":122,"state":113,"zip":123,"country":83,"countryCode":84,"cosmosGeoPoint":124,"geoPoint":128,"contacts":26},"Clinical Trials Research Institute","Thousand 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Rouge","Louisiana","70809",{"type":86,"coordinates":184},[185,186],-91.18747,30.44332,{"lat":186,"lon":185},{"facility":189,"status":79,"city":190,"state":191,"zip":192,"country":83,"countryCode":84,"cosmosGeoPoint":193,"geoPoint":197,"contacts":26},"Minnesota Clinical Study Center","New Brighton","Minnesota","55112",{"type":86,"coordinates":194},[195,196],-93.20189,45.06552,{"lat":196,"lon":195},{"facility":199,"status":79,"city":200,"state":201,"zip":202,"country":83,"countryCode":84,"cosmosGeoPoint":203,"geoPoint":207,"contacts":26},"DelRicht Research (Town Center Dermatology)","Wildwood","Missouri","63040",{"type":86,"coordinates":204},[205,206],-90.6629,38.58283,{"lat":206,"lon":205},{"facility":209,"status":79,"city":210,"state":211,"zip":212,"country":83,"countryCode":84,"cosmosGeoPoint":213,"geoPoint":217,"contacts":26},"Vitality Clinical Trials LLC","Woodbury","New York","11797",{"type":86,"coordinates":214},[215,216],-74.10598,41.36454,{"lat":216,"lon":215},{"facility":219,"status":79,"city":220,"state":221,"zip":222,"country":83,"countryCode":84,"cosmosGeoPoint":223,"geoPoint":227,"contacts":26},"Optima Research Boardman","Boardman","Ohio","441512",{"type":86,"coordinates":224},[225,226],-80.66285,41.02423,{"lat":226,"lon":225},{"facility":229,"status":79,"city":230,"state":231,"zip":232,"country":83,"countryCode":84,"cosmosGeoPoint":233,"geoPoint":237,"contacts":26},"DelRicht Research @Mt Pleasant Dermatology","Mt. Pleasant","South Carolina","29464",{"type":86,"coordinates":234},[235,236],-79.86259,32.79407,{"lat":236,"lon":235},{"facility":239,"status":79,"city":240,"state":231,"zip":241,"country":83,"countryCode":84,"cosmosGeoPoint":242,"geoPoint":246,"contacts":26},"AMR Clinical - Myrtle Beach","Myrtle Beach","29588",{"type":86,"coordinates":243},[244,245],-78.88669,33.68906,{"lat":245,"lon":244},{"facility":248,"status":79,"city":249,"state":250,"zip":251,"country":83,"countryCode":84,"cosmosGeoPoint":252,"geoPoint":256,"contacts":26},"Dermatology and Laser Surgery Center","Houston","Texas","77002",{"type":86,"coordinates":253},[254,255],-95.36327,29.76328,{"lat":255,"lon":254},{"facility":258,"status":79,"city":259,"state":250,"zip":260,"country":83,"countryCode":84,"cosmosGeoPoint":261,"geoPoint":265,"contacts":26},"Texas Dermatology & Laser Specialists","San Antonio","78218",{"type":86,"coordinates":262},[263,264],-98.49363,29.42412,{"lat":264,"lon":263},{"facility":267,"status":79,"city":268,"state":269,"zip":270,"country":83,"countryCode":84,"cosmosGeoPoint":271,"geoPoint":275,"contacts":26},"Jordan Valley Dermatology Center","South Jordan","Utah","84095",{"type":86,"coordinates":272},[273,274],-111.92966,40.56217,{"lat":274,"lon":273},{"facility":277,"status":79,"city":278,"state":279,"zip":280,"country":83,"countryCode":84,"cosmosGeoPoint":281,"geoPoint":285,"contacts":26},"Eurofins CRL Cosmetic LLC","Forest","Virginia","24551",{"type":86,"coordinates":282},[283,284],-79.28975,37.36375,{"lat":284,"lon":283},{"facility":287,"status":79,"city":288,"state":289,"zip":290,"country":291,"countryCode":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":26},"Innovaderm Research Inc","Montreal","Quebec","H2X2V1","Canada","CA",{"type":86,"coordinates":294},[295,296],-73.58781,45.50884,{"lat":296,"lon":295},{"type":299,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100656058","phase-2-phase-23-efficacy-and-safety-of-pp405-in-adult-males-with-nhs-type-ivv-100656058",false,"NCT07819435","Phase 2\u002F3 Efficacy and Safety of PP405 in Adult Males","A Randomized, Multicenter, Double-blind, Vehicle-controlled, Phase 2\u002F3 Study to Assess Efficacy and Long-Term Safety of PP405 in Adult Males With Androgenetic Alopecia","AWAKEN","Inclusion Criteria:\n\n1. Males (assigned at birth) aged 18 to 55 years, inclusive at time of consent.\n2. Able and willing to provide written informed consent\n3. Must have been experiencing Androgenetic Alopecia (AGA) for at least 6 months prior to screening.\n4. Have a modified Norwood-Hamilton score of Type IV or Type V\n5. Agree to comply with protocol procedures\n\nExclusion Criteria:\n\n1. Concomitant diagnosis of non-AGA forms of alopecia.\n2. Use of other hair loss treatments within periods specified in protocol.\n3. Use of excluded medications and procedures as specified in protocol.\n4. Diagnosis of other medical conditions as specified in protocol.\n5. Any disease or medical condition that, in the opinion of the Investigator, would prevent the subject from participating in the study or might confound study results.","MALE","18 Years","55 Years",{"count":312,"type":313},600,"ESTIMATED","INTERVENTIONAL",[316,317],"PHASE2","PHASE3","The study is designed to validate efficacy and long term safety of PP405.",[320],"Androgenetic Alopecia","2026-10-03",{"date":323,"type":324},"2026-10-07","ACTUAL",{"date":326,"type":324},"2026-09-21",{"date":328,"type":313},"2028-06",{"name":5,"class":6},22]