[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643341":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":67,"collaborators":71,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":37,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":37,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":102,"whyStopped":37,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Indonesia University","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser + Hydrogel","EXPERIMENTAL","Participants will undergo fractional CO₂ laser treatment followed by application of the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid according to the study protocol.",[13,14],"Device: CO2 Fractional Laser","Other: Hydrogel",{"label":16,"type":17,"description":18,"interventionNames":19},"Fractional CO₂ Laser + Placebo","PLACEBO_COMPARATOR","Participants will undergo fractional CO₂ laser treatment followed by application of a placebo gel according to the study protocol.",[13,20],"Other: Placebo gel",{"label":22,"type":10,"description":23,"interventionNames":24},"Hydrating Gel Only","Participants will receive the hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid without fractional CO₂ laser treatment according to the study protocol.",[14],[26,33,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","CO2 Fractional Laser","Fractional CO₂ laser treatment performed according to the study protocol by a qualified dermatologist.",[16,9],[32],"laser treatment",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Hydrogel","Hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid.",[22,9],null,{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Placebo gel","Placebo gel matched in appearance and application method to the investigational hydrating gel.",[16],[43],{"name":44,"affiliation":45,"role":46},"Irma Bernadette S. Sitohang, Prof. Dr. dr.","Universitas Indonesia Hospital","PRINCIPAL_INVESTIGATOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":37,"email":51},"CONTACT","+62818130761","irma_bernadette@yahoo.com",[53],{"facility":45,"status":37,"city":54,"state":55,"zip":37,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Depok","West Java","Indonesia","ID",{"type":59,"coordinates":60},"Point",[61,62],106.81861,-6.4,{"lat":62,"lon":61},[65,66],{"name":44,"role":49,"phone":50,"phoneExt":37,"email":51},{"name":44,"role":46,"phone":37,"phoneExt":37,"email":37},{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","Dr.dr.Irma Bernadette, SpKK (K)","Prof. Dr. dr. Irma Bernadette S., SpDVE, Subsp D.K.E",[72,75,77],{"name":73,"class":74},"Indonesian Society of Dermatology and Venereology","UNKNOWN",{"name":76,"class":74},"College of Dermatologist and Venereologist",{"name":78,"class":6},"Indonesia Medical Education and Research Institute","100643341","effectiveness-and-safety-of-a-hydrating-gel-containing-polyvinyl-pyrrolidine-algin-and-hyaluronic-acid-applied-after-and-without-fractional-co-laser-therapy-100643341",false,"NCT07639151","Effectiveness and Safety of a Hydrating Gel Containing Polyvinyl Pyrrolidine, Algin and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy","Effectiveness and Safety of a Hydrating Gel Containing Aqua, Carrageenan, Polyvinyl Pyrrolidon, Algin, Gellan Gum, and Hyaluronic Acid Applied After and Without Fractional CO₂ Laser Therapy","Inclusion Criteria:\n\n1. Female participants aged 18-60 years.\n2. Patients attending the Dermatology and Venereology Outpatient Clinic of Universitas Indonesia Hospital (RSUI) who will receive the hydrating gel either following fractional CO₂ laser treatment or without undergoing the fractional CO₂ laser procedure.\n3. Patients who will undergo or have undergone a priming regimen with topical retinoic acid preparations at concentrations of at least 0.025%, 0.05%, or 0.1% for at least 2 weeks prior to fractional CO₂ laser treatment, or prior to study participation in the non-laser group.\n4. Willing to participate in the study and have provided written informed consent after receiving adequate explanation regarding the study.\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or currently using oral contraceptives at the time of assessment.\n2. History of systemic retinoid use within the past 3 months.\n3. History of or current treatment for hormonal\u002Fendocrine disorders or other serious medical conditions.\n4. Currently receiving immunosuppressive therapy.\n5. Participants who are unable or unwilling to comply with the study protocol and treatment regimen.",true,"FEMALE","18 Years","60 Years",{"count":91,"type":92},51,"ESTIMATED","INTERVENTIONAL",[95],"NA","The purpose of this interventional study is to evaluate the effectiveness and safety of a hydrating gel containing aqua, carrageenan, polyvinyl pyrrolidone, algin, gellan gum, and hyaluronic acid. The study will assess the gel's ability to support optimal skin recovery following fractional CO₂ laser therapy and its effectiveness and safety as a daily adjunctive skincare treatment. Outcomes related to skin hydration, skin barrier function, tolerability, and adverse events will be evaluated throughout the study period.\n\nFemale participants aged 18 to 60 years who provide informed consent will be enrolled in this study. Participants will undergo a 2-week priming period with topical tretinoin prior to fractional CO₂ laser treatment. Clinical evaluations will be performed at baseline, immediately after the laser procedure, and on Days 3, 7, and 14 post-treatment. Assessments conducted by a board-certified dermatologist will include dermoscopy, TEWAmeter assessment, erythema assessment, and evaluation of pain and discomfort using a Visual Analog Scale (VAS).",[98,99,100,34],"Hydration","Carbon-dioxide Laser","Laser Therapy",[34,28,98],"NOT_YET_RECRUITING","2026-06-05",{"date":105,"type":106},"2026-06-10","ACTUAL",{"date":108,"type":92},"2026-06",{"date":110,"type":92},"2026-09",{"name":69,"class":6},1]