[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":38,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":38,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":38,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":93,"whyStopped":38,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Topical 5% Spironolactone Gel nano-formulation.","EXPERIMENTAL","Participants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris.",[13],"Drug: Spironolactone 5% Topical Gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Topical 0.1% Adapalene Gel","ACTIVE_COMPARATOR","Participants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety.",[19],"Drug: Adapalene 0.1% Topical Gel",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Spironolactone 5% Topical Gel","This is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks.",[9],[27,28,29],"Topical Spironolactone","Spironolactone Nano-Gel","Spironolactone 5% Gel",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Adapalene 0.1% Topical Gel","A third-generation retinoid applied once daily at night to the opposite half of the face.",[15],[35,36,37],"Topical Adapalene","Adapalene Gel","Adapalene 0.1%",null,[40],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"Mai Ahmed Ahmed","CONTACT","01123095269","Mai1998530@gmail.com",[46],{"facility":5,"status":38,"city":47,"state":38,"zip":38,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Asyut","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.18368,27.18096,{"lat":54,"lon":53},[57],{"name":5,"role":42,"phone":58,"phoneExt":38,"email":59},"08822080150","vp_grad@aun.edu.eg",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Mai Ahmed Thabet Ahmed","Resident at dermatology, venereology and andrology department","100629378","phase-2-topical-5-spironolactone-gel-versus-01-adapalene-gel-for-acne-vulgaris-a-randomized-split-face-study-100629378",false,"NCT07473895","Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study","Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study","Inclusion Criteria:\n\nAge: 18-45 years old.\n\n* Patients with mild to moderate bilateral acne vulgaris on the face.\n* Presence of non-inflammatory acne (open and closed comedones).\n* Presence of inflammatory papules and pustules.\n\nExclusion Criteria:\n\n* Pregnancy and lactation.\n* Patients taking oral contraceptive pills or any hormonal treatment.\n* Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.\n* Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.","ALL","18 Years","45 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions.\n\nThis study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response.\n\nParticipants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed.\n\nThe results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.",[82],"Acne Vulgaris",[84,85,86,87,88,89,90,91,92],"Acne vulgaris","Spironolactone","Adapalene","Topical therapy","Split-face study","Antiandrogen thearapy","Nano-Formulation","Dermatology","Acne treatment","NOT_YET_RECRUITING","2026-03-15",{"date":96,"type":97},"2026-03-17","ACTUAL",{"date":99,"type":76},"2026-04",{"date":101,"type":76},"2026-12",{"name":5,"class":6},1]