[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611142":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":42,"responsibleParty":62,"collaborators":22,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":22,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":22,"overallStatus":85,"whyStopped":22,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Biocoz Global Pte. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SPM™ Application Area","EXPERIMENTAL","Participants will apply the SPM™ topical cosmetic formulation twice daily for six (6) weeks to a designated skin area (e.g., right arm). SPM™ is a peptide-based cosmetic formulation containing amino acids, vitamins, and recombinant human serum albumin, designed to support healthy skin appearance, hydration, and barrier function.\n\nA matching contralateral site (e.g., left arm) will remain untreated and serve as the within-subject control for comparison. No product will be applied to this area.\n\nSkin biopsies (3-6 mm) will be obtained from both the treated and untreated sites at two timepoints:\n\nBaseline (before starting SPM™ application), and\n\nEnd of the 6-week product-use period.\n\nBiopsy samples from both sites will be analyzed in parallel to characterize cosmetic skin attributes (e.g., structure, hydration-related markers, and barrier-related characteristics) and to compare changes between the SPM™-treated and untreated control areas.",[13,14,15],"Procedure: Skin biopsy","Other: Corneometer® Measurement","Other: Tewameter® Measurement",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"PROCEDURE","Skin biopsy","Skin biopsies (3-6 mm) will be performed at two time points:\n\nBaseline (prior to initiation of SPM™ application)\n\nEnd of product-use period (after 6 weeks of twice-daily application)\n\nThese samples will be analyzed for cosmetic-related skin structure and protein expression characteristics (e.g., filaggrin levels and barrier markers).",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"OTHER","Corneometer® Measurement","Noninvasive skin hydration assessment using the Corneometer® instrument at baseline and after 6 weeks. The device quantifies the moisture content of the stratum corneum through dielectric constant measurement.",[9],{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"Tewameter® Measurement","Noninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period.",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":22,"email":37},"Guillermo Barahona","CONTACT","4106038343","guillermobarah@icloud.com",{"name":39,"role":35,"phone":40,"phoneExt":22,"email":41},"Daniel Rahmann","3107707917","daniel@drchristiela.com",[43],{"facility":44,"status":22,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Project Quality of Life","West Hollywood","California","90069","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-118.36174,34.09001,{"lat":54,"lon":53},[57,59],{"name":39,"role":35,"phone":58,"phoneExt":22,"email":41},"310-907-8348",{"name":60,"role":61,"phone":22,"phoneExt":22,"email":22},"Christie Prendergast, DO","PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100611142","evaluation-of-spm-topical-cosmetic-application-on-skin-appearance-hydration-and-barrier-support-in-healthy-adults-100611142",false,"NCT07236736","Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults","SPMT","Inclusion Criteria:\n\n1. Generally healthy with no systemic or active dermatologic diseases.\n2. Willing and able to apply topical product daily for 6 weeks.\n3. Able to provide written informed consent.\n4. Willing to undergo skin biopsies and follow study procedures.\n\nExclusion Criteria:\n\n1. History of skin cancer or other malignancy within the past 10 years.\n2. Active or chronic dermatologic conditions (e.g., eczema, psoriasis, acne, rosacea).\n3. Known allergy or sensitivity to components of the investigational product.\n4. Current use of systemic corticosteroids or immunosuppressants.\n5. Pregnancy or breastfeeding.\n6. Any condition that, in the investigator's opinion, would interfere with study participation or pose additional risk.",true,"ALL","20 Years","75 Years",{"count":76,"type":77},10,"ESTIMATED","INTERVENTIONAL",[80],"NA","This is an exploratory, cosmetic-use study evaluating the effects of Super Protein Multifunction (SPM™), a topical peptide-based formulation, on skin appearance, hydration, and barrier-related characteristics in healthy adults. The study aims to collect preliminary biophysical and histologic data on cosmetic skin changes following six weeks of SPM™ use. Participants will apply the product to a designated skin area while a matched contralateral area serves as the untreated comparison site. Skin hydration, transepidermal water loss (TEWL), and tissue markers of skin structure and barrier integrity will be assessed before and after product use. The study includes noninvasive measurements and small punch biopsies at two timepoints.",[83,84],"Healthy Skin","Skin Hydration","NOT_YET_RECRUITING","2025-12-17",{"date":88,"type":89},"2025-12-19","ACTUAL",{"date":91,"type":77},"2026-01-30",{"date":93,"type":77},"2027-06-30",{"name":5,"class":6},1]