[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631756":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":30,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":91,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tarumanagara University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"A","EXPERIMENTAL","Use Mediklin TR",[13],"Combination Product: Mediklin TR",{"label":15,"type":10,"description":16,"interventionNames":17},"B","Group B received Solanum Night Cream",[18],"Combination Product: Solanum Night Cream",{"label":20,"type":10,"description":21,"interventionNames":22},"C","Group C received 10% SM-hUCMSC secretome gel.",[23],"Combination Product: Gel Sekretome SM-hUCMSC 10%",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"COMBINATION_PRODUCT","Mediklin TR","-Mediklin TR (Clindamisin + Retinoid)",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Solanum Night Cream","Solanum Night Cream (Clindamisin + Retinoid + Dexamethasone)",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Gel Sekretome SM-hUCMSC 10%","The secretome was derived from human umbilical cord mesenchymal stem cells (SM-hUCMSC) cultured up to passage 6 in MEM-α medium without growth supplements, incubated under hypoxic conditions (5% O₂) for 72 hours, and the conditioned medium was stored at -80°C before being formulated into a 10% gel.",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Yohanes Firmansyah, M.H., M.M., M.Biomed., M.K.M.,","CONTACT","+6281297934375","yohanes@fk.untar.ac.id",[46],{"facility":47,"status":30,"city":48,"state":30,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":30},"Klinik Precious Me","Tangerang","Indonesia","ID",{"type":52,"coordinates":53},"Point",[54,55],106.63,-6.17806,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Yohanes Firmansyah, dr, MH, MM","Clinical Officer",[62],{"name":63,"class":64},"Universitas Tarumanagara","UNKNOWN","100631756","phase-1-comparative-effectiveness-of-clindamycin-retinoid-clindamycin-retinoid-dexamethasone-and-10-sm-hucmsc-secretome-gel-in-the-improvement-of-mild-to-moderate-acne-vulgaris-100631756",false,"NCT07504822","Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM-hUCMSC Secretome Gel in the Improvement of Mild-to-Moderate Acne Vulgaris","Comparative Effectiveness of Clindamycin-Retinoid, Clindamycin-Retinoid-Dexamethasone, and 10% SM-hUCMSC Secretome Gel in the Improvement of Mild-to-Moderate Acne Vulgaris: A Quasi-Experimental Study","Acne Vulgaris","Inclusion Criteria:\n\n* Age 15-40 years.\n* Clinical diagnosis of mild to moderate acne vulgaris on the facial area.\n* Primary lesion location on the face, with a total lesion count meeting the above criteria.\n* Not currently using topical or systemic acne therapy within: the past 2 weeks for topical therapy; the past 4 weeks for systemic therapy (oral antibiotics, isotretinoin, or systemic steroids).\n* Willing to use only the treatment regimen provided by the investigators on the facial area throughout the study period.\n* Willing to adhere to the scheduled follow-up visits (weeks 0, 2, 4, and 8) and to sign informed consent.\n\nExclusion Criteria:\n\n* Presence of other facial skin diseases that may interfere with acne assessment (e.g., rosacea, contact dermatitis, impetigo, fungal infections, herpes, etc.).\n* History of hypersensitivity or allergy to clindamycin, retinoids, topical corticosteroids, or any components of the secretome gel.\n* Use of oral isotretinoin within the past 6 months.\n* Pregnancy or breastfeeding.\n* History of severe immunological disorders or uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, severe liver or kidney disease).\n* Presence of extensive open wounds or active infections on the face.\n* Undergoing aggressive facial cosmetic procedures within the past 3 months (e.g., ablative laser, deep chemical peeling, dermabrasion).","ALL","15 Years","40 Years",{"count":77,"type":78},189,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The goal of this clinical trial is to etermine and compare the effectiveness of three therapeutic regimens for mild to moderate acne vulgaris, such as, clindamycin-retinoid combination, clindamycin-retinoid-dexamethasone combination, and sekretome SM-hUCMSC 10% gel. The main questions it aims to answer are :\n\n* Is there a change in the number of inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones) before and after treatment in each treatment group?\n* Is there a difference in the reduction of acne vulgaris severity scores among the three treatment groups?\n* Are there differences in the rate of clinical improvement (time required to achieve a certain reduction in lesion count or severity score) among the treatment groups?\n* What are the incidence and characteristics of local adverse effects (erythema, burning sensation, skin dryness, irritation, hypo-\u002Fhyperpigmentation, and others) in each treatment group?\n* Are there differences in the impact of each therapeutic regimen on the risk of acne scar formation and improvement in skin quality (texture, elasticity, and color homogeneity)?\n* Does secretome gel demonstrate sufficient clinical potential and urgency as a safer and more prospective topical therapeutic alternative for acne vulgaris compared with retinol-clindamycin and retinol-clindamycin-dexamethasone 0.1% combinations?\n\nParticipants will be allocated into three groups using simple block randomization.\n\n* Group A will receive a combination of clindamycin and a retinoid, applied thinly to the entire facial area once daily at night.\n* Group B will receive a combination of clindamycin, a retinoid, and dexamethasone, with the same method of application as Group A.\n* Group C will receive 10% SM-hUCMSC secretome gel, applied thinly to acne-affected areas twice daily (morning and night).",[71],[86,87,88,89,90],"Acne vulgaris","Clindamycin","Dexamethasone","Retinoid","Secretome","NOT_YET_RECRUITING","2026-03-28",{"date":94,"type":95},"2026-04-01","ACTUAL",{"date":97,"type":78},"2026-04-18",{"date":99,"type":78},"2028-01-18",{"name":59,"class":6},1]