[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603485":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":47,"collaborators":25,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Secretome raw material group","EXPERIMENTAL","Group A, the treatment group, used Secretome (raw material) 3ml 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.",[13,14],"Drug: Concentrated secretome Injection 3 mL","Drug: Concentrated secretome Injection 3 mL with addition of TGF Beta 3",{"label":16,"type":10,"description":17,"interventionNames":18},"Secretome raw material with addition of TGF Beta 3 group","Group B, the treatment group, used Secretome (raw material) 3ml with addition of TGF Beta 3 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.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Concentrated secretome Injection 3 mL","The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by Dr. Cipto Mangunkusumo Hospital 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.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Concentrated secretome Injection 3 mL with addition of TGF Beta 3","The secretome used in this research comes from mesenchymal stem cells from adipose tissue produced by Dr. Cipto Mangunkusumo Hospital 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 after the secretome is ready, TGF beta 3 will be added to secretome",[9,16],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Prof. Dr. dr. Irma Bernadette S. Sitohang, Sp.DVE, Subsp.DKE IBSS Irma IBSS M.D, Ph.D, M.D, Ph.D","CONTACT","+62818130761","irma_bernadette@yahoo.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":25,"geoPoint":25,"contacts":44},"Dr. Cipto Mangunkusumo Hospital","Central Jakarta","D.k.i Jakarta","10430","Indonesia","ID",[45],{"name":46,"role":33,"phone":34,"phoneExt":25,"email":35},"irma bernadette IBS Irma Bernadette, M.D, Ph.D, M.D, Ph.D",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dr.dr.Irma Bernadette, SpKK (K)","Prof. M.D, Ph.D (Principal Investigator and Clinical Professor)","100603485","secretome-tgf-beta-3-100603485",false,"NCT07137130","Secretome TGF Beta 3","Development Of Adipose-Derived Mesenchymal Stem Cells Secretome (ADMSCS) Based Products From Stem Cell Conditioned Medium For Melasma Therapy","TGF Beta 3","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":64,"type":65},34,"ESTIMATED","INTERVENTIONAL",[68],"NA","A therapeutic modality currently being developed for melasma is secretome. Secretome is a bioactive molecule secreted by mesenchymal stem cells in a conditioned medium containing a large number of growth factors, cytokines, various macromolecules, and extracellular vesicles, including microvesicles and exosomes, that can stimulate various biological reactions, particularly in modulating new tissue formation. Secretome can provide a depigmenting effect by increasing the proliferation and migration of epidermal keratinocytes, which contain melanin pigment, in line with increased fibroblast synthesis.\n\nSecretomes contain various cytokines and growth factors, one of which is transforming growth factor (TGF)-β. TGF-β is primarily secreted by fibroblasts (FB) and, to a lesser extent, by keratinocytes, and plays a crucial role in regulating melanocyte function. TGF-β has been reported to inhibit cAMP\u002Fprotein kinase A signaling and induce GLI2, which then suppresses microphthalmia-associated transcription factor (MITF), a central transcription factor in melanogenesis. A study by Moon et al. in Korea examined TGF-β3. Moon et al. examined the effects of TGF-β3 on melanogenesis in human melanocytes co-cultured with skin cells irradiated with ultraviolet (UV) light, and in UV-irradiated human skin. The results showed that UVB irradiation or stem cell factor (SCF)\u002Fendothelin-1 (ET-1) increased melanogenesis. TGF-β3 effectively inhibited melanin accumulation and tyrosinase activity by downregulating the extracellular signal-regulated kinase (ERK)\u002Fmicrophthalmia-associated transcription factor (MITF) pathway. TGF-β3 increased the expression of keratinocyte differentiation markers.\n\nMechanistically, TGF-β3 inhibits melanogenesis by inhibiting MITF expression, which is regulated by ERK. TGF-β1 reduces MITF but at the risk of inducing skin fibrosis. However, in the study by Moon et al., the aforementioned TGF Beta 1 function was not found in TGF-β3. Furthermore, TGF-β3 restored skin differentiation function in UV-irradiated keratinocytes.\n\nTo date, there have been no clinical trials comparing intradermal injection of concentrated secretome with intradermal injection of concentrated secretome with the addition of TGF-β3 as a melasma therapy in Indonesia, thus encouraging researchers to conduct further research.",[71],"Melasma","NOT_YET_RECRUITING","2025-08-15",{"date":75,"type":76},"2025-08-22","ACTUAL",{"date":78,"type":65},"2026-02-14",{"date":80,"type":65},"2026-12-20",{"name":5,"class":6},1]