[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555771":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":47,"responsibleParty":72,"collaborators":30,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":30,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":30,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":30,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A (Secretom group)","EXPERIMENTAL","Group A, the treatment group, used Secretom 2ml Intradermal injection, Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.",[13],"Drug: Concentrated secretome Injection 2mL",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B (Triple Combination Group)","Group B, the treatment group, getting sunscreen cream in the morning and triple combination (Refaquin) cream at night and facial soap that can be used in the morning and evening.",[18],"Drug: Triple Combination Cream",{"label":20,"type":10,"description":21,"interventionNames":22},"Group C (Tranexamic Acid Group)","Group C, the treatment group, used Intradermal Injection of Tranexamic Acid 10mg\u002FmL and 25mg\u002FmL split face , Sunscreen in the morning and used Tretinoin cream 0,05% at night and cleanser which was used in the morning and evening before using the cream.",[23],"Drug: Tranexamic acid injection",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Concentrated secretome Injection 2mL","The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by IPT RSCM Stem Cell Medical Technology. The secretome produced by mesenchymal stem cells is collected, centrifuged to separate it from debris, and followed by filtration with a 0.22 μm pore filter to ensure sterility. Next, the concentration process is carried out using tangential flow filtration with the Spin-X UF 500® concentrator, packaged, and stored at -80 degrees Celsius. The product used is a sterile product, which is tested for sterility and total protein content. When it is to be used, the secretome is removed from the freezer, warmed (thawing), and injected into the patient according to a predetermined method.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Tranexamic acid injection","1. Tranexamic acid 25 mg\u002Fml is prepared by taking tranexamic acid in a vial 250 mg\u002F5 ml as much as 0.5 ml (25 mg) using a 1 ml syringe and diluted with 0.5 ml 0.9% NaCl solution just before being injected into the SP.\n2. Tranexamic acid 10 mg\u002Fml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg\u002F5 ml vial using a 1 ml syringe and diluting it with 0.8 ml of 0.9% NaCl solution for a moment. before injection into the Subject\n\n2\\. Tranexamic acid 10 mg\u002Fml is prepared by taking 0.2 ml (10 mg) of AT in a 250 mg\u002F5 ml vial using a 1 ml syringe and diluting it with 0.9% normal saline (NS) 0.8 ml just before injection into the Subject",[20],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Triple Combination Cream","1. Apply sunscreen SPF ≥30 in the morning on 2 knuckles\n2. Apply triple combination cream (Refaquin) containing hydroquinone 40 mg, tretinoin 0.5 mg, and fluocinolone acetonide 0.1 mg at night all over the face except the area around the eyes, 1 fingertip unit (FTU) or 1 knuckle.",[15],[40,45],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang","CONTACT","+62818130761","irma_bernadette@yahoo.com",{"name":46,"role":42,"phone":43,"phoneExt":30,"email":44},"Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) Sitohang Sitohang",[48,64],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Clinical Research Supporting Unit- Faculty of Medicine, University of Indonesia","RECRUITING","Jakarta Pusat","DKI Jakarta","10430","Indonesia","ID",{"type":57,"coordinates":58},"Point",[59,60],106.8223,-6.1818,{"lat":60,"lon":59},[63],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},{"facility":65,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Dr. Cipto Mangunkusumo Hospital",{"type":57,"coordinates":67},[59,60],{"lat":60,"lon":59},[70],{"name":71,"role":42,"phone":43,"phoneExt":30,"email":44},"Irma Bernadette Sitohang, MD",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Dr.dr.Irma Bernadette, SpKK (K)","Prof. Dr. dr. Irma Bernadette S. Sitohang, SpKK(K)","100555771","development-of-products-based-on-secretom-from-stem-cell-conditioned-medium-for-melasma-therapy-100555771",false,"NCT06516419","Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy","Inclusion Criteria:\n\n* Women diagnosed with melasma.\n* Women without melasma and have areas of skin that are clinically free of lesions for SP control.\n* 30-60 years old.\n* Fitzpatrick skin type IV-V.\n* Willing to be a research subject by signing a research consent form (Informed Consent).\n\nExclusion Criteria:\n\n* Pregnant and breastfeeding women.\n* Currently using hormonal contraception or have ever used contraception hormones in the last 6 months.\n* Using topical therapy for melasma, for example corticosteroids, tretinoin, hydroquinone, and other therapies that whiten or brighten the skin in the last 2 weeks.\n* Using topical triple combination cream therapy for at least 3 months and did not show significant improvement\n* Using systemic therapy for melasma, for example antioxidants or tranexamic acid in the last 4 weeks.\n* History of superficial peeling therapy in the last 4 weeks.\n* History of deep peeling therapy, laser or mechanical abrasion in the last 6 months.\n* Using drugs that are photosensitizers such as tetracycline, phenytoin, carbamazepine, spironolactone.\n* History of blood clotting disorders or on blood thinning therapy.\n* Allergy to tranexamic acid.\n* Have other skin complaints that may interfere with the evaluation of melasma, for example post-inflammatory hyperpigmentation, Hori's nevus, Ota's nevus, pigmented contact dermatitis, and other pigmentation disorders\n* Difficulty complying with treatment.",true,"FEMALE","30 Years","60 Years",{"count":87,"type":88},90,"ESTIMATED","INTERVENTIONAL",[91],"NA","This research is a clinical study with a single-blind randomized clinical trial design (randomized controlled trial) in RSCM-FKUI\n\nThis study aims to Assess the effectiveness and safety of intradermal concentrated secretome injection therapy, triple combination cream, and intradermal tranexamic acid injection in melasma patients, determine the quality of life profile of melasma patients after triple combination cream therapy in melasma therapy, and determine SOD levels in melasma patients.\n\nThis research will be attended by 90 research subjects",[94],"Melasma","2024-07-18",{"date":97,"type":98},"2024-07-24","ACTUAL",{"date":100,"type":98},"2024-02-13",{"date":102,"type":88},"2025-03-30",{"name":74,"class":6},2]