[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575671":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":40,"studyPopulation":30,"armGroups":41,"interventions":59,"overallOfficials":30,"centralContacts":89,"locations":99,"responsibleParty":117,"collaborators":120,"id":128,"slug":30,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":30,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":30,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":156,"whyStopped":30,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Indonesia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":30,"otherOutcomes":30},[9,13,15,18,21,24,27],{"measure":10,"description":11,"timeFrame":12},"Change of acne severity","Based on global acne severity scale (GEA score). On a scale of 0-5, 0 indicates no lesion, while 5 indicates very severy acne","Re-evaluation on day 28, 56 and 84 of therapy",{"measure":10,"description":14,"timeFrame":12},"Based on Indonesia Acne Expert Meeting scale (IAEM scale). the scale consists of mild, moderate and severe.",{"measure":16,"description":17,"timeFrame":12},"total of inflammation lesion and non inflammation lesion","The total lesion will be examined by dermatologist",{"measure":19,"description":20,"timeFrame":12},"acne sequelae","The acne sequelae will be examined by dermatologist",{"measure":22,"description":23,"timeFrame":12},"Quality of life","Based on acne quality of life (Acne-QoL). Total score of acne-QoL is 0-114, the higher score interprets better quality of life of acne vulgaris patient",{"measure":25,"description":26,"timeFrame":12},"Erythema severity","based on clinician erythema assessment scale (CEA scale). on the scale of 0-4. 0 indicates no erythema, while 4 indicates severe erythema",{"measure":28,"description":29,"timeFrame":12},"Facial analysis","The facial analysis will be done by using janus facial analysis system",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":37},"DOUBLE",[38,39],"PARTICIPANT","OUTCOMES_ASSESSOR","This study is a clinical study with randomized controlled trial design to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This study will be conducted in three Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Bali (Rumah Sakit Umum Pusat Prof. Dr. I.G.N.G Ngoerah). Group 1 will receive placebo cleanser, placebo combination cream, and placebo spot cream every morning and evening, and then placebo cleanser, placebo combination cream and adapalene 0,1% every night. Group 2 will receive cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and spot cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, every morning and evening, and then cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and adapalene 0,1% cream every night. All participant will be evaluated in day 28, 56, and 84. Therapy evaluation will be assessed by dermatologist based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Clinician Erythema Assessment (CEA), Total of Inflammation and Non-Inflammation lesions, Acne Sequelae, facial skin analysis with Janus Skin Facial Analysis, and evaluation of quality of life using Acne-Quality of Life (Acne-QoL).",[42,51],{"label":43,"type":44,"description":45,"interventionNames":46},"Placebo","PLACEBO_COMPARATOR","this arm will receive placebo cleanser, placebo combination cream, and placebo spot cream every morning and evening, and then placebo cleanser, placebo combination cream and adapalene 0,1% every night",[47,48,49,50],"Drug: Adapalene 0,1% cream","Drug: placebo cleanser","Drug: placebo cream combination","Drug: placebo spot cream",{"label":52,"type":53,"description":54,"interventionNames":55},"Treatment","ACTIVE_COMPARATOR","this arm will receive cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and spot cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, every morning and evening, and then cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and adapalene 0,1% cream every night",[56,57,58,47],"Drug: Cleanser","Drug: Combination cream","Drug: spot cream",[60,65,69,73,77,81,85],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":30},"DRUG","Cleanser","Cleanser consist of Triethyl citrate and Pyruvic acid, will be given to subjects to be applied every morning, evening and night in group 2",[52],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":30},"Combination cream","combination cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid will be given to subjects to be applied every morning, evening and night in group 2",[52],{"type":61,"name":70,"description":71,"armGroupLabels":72,"otherNames":30},"spot cream","spot cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, will be given to subjects to be applied every morning and evening in group 2",[52],{"type":61,"name":74,"description":75,"armGroupLabels":76,"otherNames":30},"Adapalene 0,1% cream","adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2",[43,52],{"type":61,"name":78,"description":79,"armGroupLabels":80,"otherNames":30},"placebo cleanser","placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1",[43],{"type":61,"name":82,"description":83,"armGroupLabels":84,"otherNames":30},"placebo cream combination","placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1",[43],{"type":61,"name":86,"description":87,"armGroupLabels":88,"otherNames":30},"placebo spot cream","placebo spot cream will be given to subjects to be applied every morning and evening in group 1",[43],[90,95],{"name":91,"role":92,"phone":93,"phoneExt":30,"email":94},"Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E Sitohang","CONTACT","+62818130761","irma_bernadette@yahoo.com",{"name":96,"role":92,"phone":97,"phoneExt":30,"email":98},"dr. Lilik Norawati, Sp.DVE","+628121107149","liliknora21@gmail.com",[100],{"facility":101,"status":30,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"Rumah Sakit Pusat Angkatan Darat Gatot Soebroto","Jakarta","Jakarta Pusat","10410","Indonesia","ID",{"type":108,"coordinates":109},"Point",[110,111],106.84513,-6.21462,{"lat":111,"lon":110},[114,116],{"name":115,"role":92,"phone":93,"phoneExt":30,"email":94},"Prof. Dr. dr. Irma Bernadette, Sp.DVE, Subsp. D.K.E",{"name":96,"role":92,"phone":97,"phoneExt":30,"email":98},{"type":118,"investigatorFullName":119,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Dr.dr.Irma Bernadette, SpKK (K)",[121,124,126],{"name":122,"class":123},"Indonesian Society of Dermatology and Venereology","UNKNOWN",{"name":125,"class":123},"College of Dermatologist and Venereologist",{"name":127,"class":6},"Indonesia Medical Education and Research Institute","100575671",false,"NCT06775314","The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol","The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol As Adjuvant Therapy for Mild to Moderate Acne Vulgaris","Inclusion Criteria:\n\n* Female and male aged 15-50 years\n* mild to moderate acne vulgaris according to IAEM (Indonesian Acne Expert Meeting) scale and GEA ( Global Acne Severity) scale\n* The subject is willing to participate in the study until it is finished\n\nExclusion Criteria:\n\n* History of allergy to dermocosmetic products\n* Undergoing other acne therapy, medication, or invasive action in the last month\n* Pregnant or breastfeeding subjects","ALL","15 Years","50 Years",{"count":138,"type":139},102,"ESTIMATED","INTERVENTIONAL",[142],"PHASE3","The goal of this clinical study is to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This research aims to answer the main questions, those are :\n\n1. How is the effectiveness of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris?\n2. How is the safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris?\n\nParticipants are males and females between 15-50 years old. Participants will be examined by dermatologist, and will be photographed in five different positions, and also evaluated by janus facial analysis system. The participants are asked to use Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy. The participants will be evaluated in 28, 56 and 84 days after the treatment.",[145],"Acne Vulgaris",[147,148,149,150,151,152,153,154,155],"acne vulgaris","Triethyl citrate","Pyruvic acid","Ethyl linoleate","GT peptide-10","Salicylic acid 0,5%","Zinc lactate","Hyaluronic acid","Honokiol","NOT_YET_RECRUITING","2025-01-14",{"date":159,"type":160},"2025-01-16","ACTUAL",{"date":162,"type":139},"2025-03-01",{"date":164,"type":139},"2025-06-30",{"name":119,"class":6},1]