[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658362":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":56,"studyPopulation":49,"armGroups":57,"interventions":71,"overallOfficials":87,"centralContacts":92,"locations":98,"responsibleParty":130,"collaborators":49,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":49,"enrollmentInfo":142,"targetDuration":49,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":158,"whyStopped":49,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Unifarco SpA","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving a combined clinical and symptomatic response","Proportion of participants achieving a combined response after one cycle of narrowband UVB phototherapy (36 ± 3 sessions), defined as:\n\n1. an absolute PASI score ≤ 3 assessed at the end-of-study visit (V3), AND\n2. a reduction ≥ 2 points on the pruritus VAS (0-10), calculated as the difference between the baseline visit (V1) and the end-of-study visit (V3).","PASI component: end-of-study visit (V3). Pruritus VAS component: change from baseline (V1) to end-of-study visit (V3). V3 occurs after 36 ± 3 UVB sessions (approximately weeks 11-18).",[14,18,22,26,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Change in Psoriasis Area and Severity Index (PASI) score (baseline to Visit 2)","Change in the Psoriasis Area and Severity Index (PASI) score from the baseline visit to the follow-up visit (V2). The PASI ranges from 0 to 72, with higher scores indicating greater psoriasis severity (worse outcome).","Baseline (D0) to Visit 2, after 12 ± 3 UVB sessions (approx. weeks 3-5)",{"measure":19,"description":20,"timeFrame":21},"Change in Psoriasis Area and Severity Index (PASI) score (baseline to end of study)","Change in the Psoriasis Area and Severity Index (PASI) score from the baseline visit to the end-of-study visit (V3). The PASI ranges from 0 to 72, with higher scores indicating greater psoriasis severity (worse outcome).","Baseline (D0) to Visit 3, after 36 ± 3 UVB sessions (approx. weeks 11-18)",{"measure":23,"description":24,"timeFrame":25},"Change in pruritus\u002Fitching Visual Analogue Scale (VAS) score (baseline to Visit 2)","Change in the pruritus\u002Fitching Visual Analogue Scale (VAS) score from baseline to the follow-up visit (V2). The pruritus\u002Fitching VAS ranges from 0 to 10, with higher scores indicating greater itching intensity (worse outcome).","Baseline (D0) to Visit 2 (approx. weeks 3-5)",{"measure":27,"description":28,"timeFrame":29},"Change in pruritus\u002Fitching Visual Analogue Scale (VAS) score (baseline to end of study)","Change in the pruritus\u002Fitching Visual Analogue Scale (VAS) score from baseline to the end-of-study visit (V3). The pruritus\u002Fitching VAS ranges from 0 to 10, with higher scores indicating greater itching intensity (worse outcome).","Baseline (D0) to Visit 3 (approx. weeks 11-18)",{"measure":31,"description":32,"timeFrame":25},"Change in dryness\u002Ftightness Visual Analogue Scale (VAS) score (baseline to Visit 2)","Change in the dryness\u002Ftightness Visual Analogue Scale (VAS) score from baseline to the follow-up visit (V2). The dryness\u002Ftightness VAS ranges from 0 to 10, with higher scores indicating greater dryness\u002Ftightness severity (worse outcome).",{"measure":34,"description":35,"timeFrame":29},"Change in dryness\u002Ftightness Visual Analogue Scale (VAS) score (baseline to end of study)","Change in the dryness\u002Ftightness Visual Analogue Scale (VAS) score from baseline to the end-of-study visit (V3). The dryness\u002Ftightness VAS ranges from 0 to 10, with higher scores indicating greater dryness\u002Ftightness severity (worse outcome).",{"measure":37,"description":38,"timeFrame":25},"Proportion with clinically relevant pruritus improvement (baseline to Visit 2)","Proportion of participants with a clinically relevant improvement, defined as a reduction ≥ 2 points on the pruritus Visual Analogue Scale (VAS) (0-10), from baseline to the follow-up visit (V2).",{"measure":40,"description":41,"timeFrame":29},"Proportion with clinically relevant pruritus improvement (baseline to end of study)","Proportion of participants with a clinically relevant improvement, defined as a reduction ≥ 2 points on the pruritus\u002Fitching Visual Analogue Scale (VAS) (0-10), from baseline to the end-of-study visit (V3).",{"measure":43,"description":44,"timeFrame":29},"Change in quality of life (Dermatology Life Quality Index - DLQI)","Change in the Dermatology Life Quality Index (DLQI) score from the baseline visit to the end-of-study visit (V3). The DLQI ranges from 0 to 30, with higher scores indicating greater impairment of quality of life (worse outcome).",{"measure":46,"description":47,"timeFrame":48},"Treatment satisfaction","Participant-reported satisfaction with the treatment received, measured with the Treatment Satisfaction Visual Analogue Scale (VAS) at the end-of-study visit (V3). The Treatment Satisfaction VAS ranges from 0 to 10, with higher scores indicating greater treatment satisfaction (better outcome).","Visit 3, after 36 ± 3 UVB sessions (approx. weeks 11-18)",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":49},"NONE","Psoriasis is a chronic, immune-mediated inflammatory skin disease frequently associated with impaired skin barrier function, dryness, pruritus, and reduced quality of life. Narrowband UVB phototherapy is a standard-of-care treatment for mild-to-moderate plaque psoriasis, but it can further compromise skin barrier integrity and hydration. Emollients containing ceramides, cholesterol, fatty acids and urea have been reported to support barrier repair, reduce transepidermal water loss, and improve tolerance to phototherapy when used as adjuvant treatments.\n\nCeramol PSOR cream is a CE-marked (Class IIa) medical device manufactured by Unifarco S.p.A., formulated with ceramides, cholesterol, fatty acids and urea, indicated for the hyperkeratotic and scaly forms of mild and\u002For moderate psoriasis. Participants will be randomized 1:1 to receive either Ceramol PSOR cream or a cosmetically similar comparator emollient cream lacking the specific functional ingredients, applied topically once daily as an adjuvant to their narrowband UVB phototherapy cycle.\n\nThe study includes three in-person visits: a baseline visit (V1, day 0, including informed consent, eligibility confirmation, and randomization), a follow-up visit (V2, after 12 ± 3 UVB sessions) and an end-of-study visit (V3, after 36 ± 3 UVB sessions). A sample size of 128 participants (allowing \\~10% loss to follow-up) will be recruited across 4 sites in Spain.",[58,65],{"label":59,"type":60,"description":61,"interventionNames":62},"Ceramol PSOR cream group - Device: Ceramol PSOR Cream","EXPERIMENTAL","Topical application of Ceramol PSOR cream once daily as an adjuvant to narrowband UVB phototherapy, throughout one phototherapy cycle (36 ± 3 sessions).",[63,64],"Radiation: Narrowband UVB Phototherapy","Device: Ceramol PSOR Cream",{"label":66,"type":67,"description":68,"interventionNames":69},"Comparator emollient cream group","PLACEBO_COMPARATOR","Topical application of a cosmetically similar comparator emollient cream, without the specific functional ingredients (ceramides, cholesterol, fatty acids, urea) present in Ceramol PSOR cream, once daily as an adjuvant to narrowband UVB phototherapy, throughout one phototherapy cycle (36 ± 3 sessions).",[63,70],"Other: Comparator Emollient Cream",[72,77,82],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":49},"RADIATION","Narrowband UVB Phototherapy","Standard-of-care narrowband ultraviolet B phototherapy administered per routine clinical practice, one cycle of 36 ± 3 sessions, delivered to all participants regardless of randomized cream assignment.",[59,66],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":49},"DEVICE","Ceramol PSOR Cream","CE-marked (Class IIa) topical medical device formulated with ceramides, cholesterol, fatty acids and urea. Applied once daily to the whole body throughout one narrowband UVB phototherapy cycle (36 ± 3 sessions).",[59],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":49},"OTHER","Comparator Emollient Cream","Cosmetic emollient cream, cosmetically similar to Ceramol PSOR cream but without ceramides, cholesterol, fatty acids or urea. Applied once daily to the whole body throughout one narrowband UVB phototherapy cycle (36 ± 3 sessions).",[66],[88],{"name":89,"affiliation":90,"role":91},"Raquel Rivera Díaz, MD","Hospital Universitario 12 de Octubre","PRINCIPAL_INVESTIGATOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":49,"email":97},"Daniel Fernández-Villa, PhD","CONTACT","(+34) 91 779 26 37","danielfvilla.imas12@h12o.es",[99,114,121],{"facility":100,"status":49,"city":101,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Hospital Universitario de La Princesa","Madrid","28006","Spain","ES",{"type":106,"coordinates":107},"Point",[108,109],-3.70256,40.4165,{"lat":109,"lon":108},[112],{"name":113,"role":95,"phone":49,"phoneExt":49,"email":49},"Mar Llamas Velasco, MD",{"facility":90,"status":49,"city":101,"state":101,"zip":115,"country":103,"countryCode":104,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"28041",{"type":106,"coordinates":117},[108,109],{"lat":109,"lon":108},[120],{"name":89,"role":95,"phone":49,"phoneExt":49,"email":49},{"facility":122,"status":49,"city":101,"state":101,"zip":123,"country":103,"countryCode":104,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},"Hospital Universitario Puerta de Hierro Majadahonda","28222",{"type":106,"coordinates":125},[108,109],{"lat":109,"lon":108},[128],{"name":129,"role":95,"phone":49,"phoneExt":49,"email":49},"Mercedes Hospital Gil, MD",{"type":131,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100658362","ceramol-psor-cream-as-an-adjuvant-treatment-in-patients-with-mild-to-moderate-psoriasis-treated-with-narrowband-uvb-phototherapy-ceramol-psor-crema-100658362",false,"NCT07849101","Ceramol PSOR Cream as an Adjuvant Treatment in Patients With Mild-to-Moderate Psoriasis Treated With Narrowband UVB Phototherapy (CERAMOL PSOR CREMA)","Multicenter, Prospective, Randomized, Open-Label, Controlled, Two-Arm, Parallel-Group, Superiority Clinical Investigation on the Use of Ceramol PSOR Cream in Patients With Mild-to-Moderate Plaque Psoriasis Treated With Narrowband UVB Phototherapy: CERAMOL PSOR CREMA Study","CERAMOL PSOR C","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of mild or moderate plaque psoriasis.\n* Body surface area (BSA) involvement of 3-10%, excluding palms and soles.\n* Planned treatment with narrowband UVB phototherapy as part of routine clinical practice.\n* Presence of at least one psoriasis-associated symptom (pruritus\u002Fburning, dryness\u002Ftightness) with a VAS score ≥ 3 at study entry.\n* Ability to understand and sign the Informed Consent Form\n* Willingness to use only the study product as the daily body moisturizer during the phototherapy cycle.\n\nExclusion Criteria:\n\n* Patients receiving systemic pharmacological treatment for psoriasis.\n* Patients receiving topical pharmacological treatment for psoriasis, or who discontinued such treatment less than one (1) week before enrollment.\n* Any active dermatological condition unrelated to psoriasis that could interfere with study results.\n* Cognitive impairment preventing completion of the study questionnaires.","ALL","18 Years",{"count":143,"type":144},128,"ESTIMATED","INTERVENTIONAL",[147],"NA","This is a multicenter, prospective, randomized, open-label, controlled clinical investigation to evaluate whether Ceramol PSOR cream, used as an adjuvant treatment, is superior to a comparator emollient cream in patients with mild-to-moderate plaque psoriasis undergoing narrowband UVB phototherapy. Participants apply the assigned cream topically once daily throughout one standard phototherapy cycle (36 ± 3 UVB sessions). The study assesses clinical response (PASI, body surface area), subjective symptoms (pruritus and dryness\u002Ftightness VAS), quality of life (DLQI), treatment satisfaction, and adherence to both the investigational product and phototherapy.",[150,151,152],"Psoriasis","Psoriasis; Plaque","Psoriasis Vulgaris",[150,154,155,156,157],"Narrowband UVB phototherapy","Adjuvant treatment","Emollient","Quality of life","NOT_YET_RECRUITING","2026-09-23",{"date":161,"type":162},"2026-09-30","ACTUAL",{"date":164,"type":144},"2026-10",{"date":166,"type":144},"2027-06",{"name":5,"class":6},3]